Polyether Ether Ketone (PEEK) Implants and the Manufacturer and User Facility Device Experience (MAUDE) Database: An Updated Review of Adverse Events and Complications.

INTRODUCTION: Polyether ether ketone (PEEK) custom implants have been fundamental in addressing bone malformations and restoring traumatic defects within the field of craniofacial surgery. Although such implants are generally considered safe and appropriate alternatives to autologous bone grafts, there has been a lack of standardized reporting of adverse events associated with PEEK implants. The purpose of this study is multi-fold: (1) to explore the current landscape of autologous and allogeneic materials utilized for bone grafting; (2) to analyze and characterize adverse events associated within PEEK implants from the widely accredited, FDA-run database, Manufacturer and User Facility Device Experience (MAUDE); and using the data, (3) to provide guidance to craniofacial surgeons using PEEK implants in their surgical practice. MATERIAL/METHODS: A retrospective review of the adverse events associated with PEEK implants were performed through the FDA-run database, Manufacturer and User Facility Device Experience (MAUDE). The database was surveyed from July 2013 to January 2023. Event types were categorized by injury or malfunction, and device-reported adverse events were recorded, respectively. RESULTS: Database search initially yielded 77 adverse event reports, but after duplicates were removed, 69 event reports were included in the analysis. These events were sorted into the following categories: device-related and patient-related. Event types were categorized by injury (48.3%) or malfunction (53.6%). The most common reported device-related adverse events were "Poor Fit" (53.6%) and "Adverse Event without Identified Use or Problem " (26.1%). The most common reported patient-related event was "Infection" (32.8%). Of these adverse event reports, 14 (20.2%) patients required a second surgery; 21(30.4%) required implant modification whereas in the operating room; 17 (24.6%) underwent implant removal. Nine (13%) patients experienced operative case delays due to implant modifications. CONCLUSION: Infection and poor fit were among the most commonly reported adverse events associated with PEEK customizable implants. Although PEEK implants have been widely implemented in addressing craniofacial bony defects, our database analysis does call for further investigation in studying the long-term outcomes associated with PEEK craniofacial implants. With such analyses and collaboration among plastic surgeons and device engineers, there is great opportunity for innovation of these devices.

Association Between Maxillary Segmentation and Perioperative Complications in Le Fort I Osteotomy.

The Le Fort I osteotomy is used to reposition the maxilla to correct numerous maxillofacial and occlusal deformities. The aim of this study was to delineate perioperative complication rates associated with Le Fort I osteotomy and determine whether the number of maxillary segments or bone grafting yielded increased complication rates. Patients undergoing Le Fort I osteotomy from 2012 to 2019 were identified from the multi-institution "National Surgical Quality Improvement Program" database using Current Procedure Terminology codes. The predictor variables of interest included maxillary segmentation defined as 1, 2, or 2 pieces and the presence or absence of bone graft. Perioperative complications were collected as the primary outcome variable, including superficial and deep space infections, wound dehiscence, airway complication, peripheral nerve injury, and hemorrhage. The secondary outcome variables included readmission and reoperation rate within the 30-day postoperative period. Complication rates were compared using multivariate analysis across groups stratified by the number of maxillary segments and inclusion of bone grafting. Of the 532 patients that met the inclusion criteria, 333 (63%) underwent 1-piece, 114 (21%) 2-piece, and 85 (16%) 2-piece Le Fort I osteotomy procedures. A total of 48 patients exhibited complications (9%), with hemorrhage (2.3%) being the most common complication observed. The number of maxillary segments was not a significant predictor of perioperative complications ( P = 0.948) nor was the use of bone grafting ( P = 0.279).

Changes in Personal Protective Equipment Practices of Craniofacial Surgeons during COVID-19: A Cross-sectional Study.

Surgeons who operate around nasal or oral airways are at particularly high risk for transmission of the severe acute respiratory syndrome coronavirus 2. This multipart study explores the changes in craniofacial surgeon preferences and practices for personal protective equipment (PPE) over the course of a worldwide pandemic. Methods: Two identical electronic survey studies, one in 2020 and one in 2022, were conducted on the use of PPE before, during, and after the pandemic among active craniomaxillofacial surgeons. Statistical changes in behaviors and preferences and differences across time points and demographic groups were evaluated. Results: The initial study included responses from 48 surgeons, and the follow-up study consisted of 36 responses. Although only 4.3% of surgeons wore N95 masks or powered air purifying respirator for craniomaxillofacial operations before the pandemic, 91.5% wore these measures during the early pandemic (P < 0.001). However, this fell to 74.3% 2 years later. Similarly, more than 95% of surgeons wore a mask in clinic during the pandemic at both time points compared to only 40.3% before the pandemic (P < 0.001). In 2020, 31.9% of surgeons planned to continue using N95 masks or powered air purifying respirator for craniofacial cases after the pandemic was over, but that fell to 11.4% in the follow-up study. Conclusions: Craniofacial surgeon practices have shifted significantly toward more protective PPE over the course of the coronavirus disease 2019 pandemic. However, this effect was dampened over the course of a protracted pandemic. Despite this, our studies indicate a long-term shift in surgeon preference that is likely to persist after the pandemic is over.

Improved Success Rate with Corticocancellous Block Compared to Cancellous-Only Trephine Technique in Alveolar Bone Grafting from the Iliac Crest.

BACKGROUND: Alveolar bone grafting is an important component of cleft lip and palate treatment, with iliac crest as the most common donor site. Although studies have attempted to quantify alveolar bone graft resorption, few have directly compared the outcomes of graft techniques. This study compared the long-term success rates of corticocancellous block to trephine cancellous-only alveolar bone grafting from the iliac crest. METHODS: A retrospective review of all cleft lip and palate patients undergoing alveolar bone grafting over 14 years was performed. Power analysis was performed to determine sample size. Data including patient demographics, surgical technique, need for repeated grafting, complications, length of hospitalization, and follow-up were collected. Statistical analyses of outcomes were performed based on initial graft technique. RESULTS: A total of 106 initial operations met criteria, with 73 using trephine technique, 30 using corticocancellous block, and three undergoing open cancellous harvest. The overall regraft rate was 40 percent, with an average follow-up of 43.5 months. Patients with corticocancellous block grafting had significantly lower rates of repeated grafting compared to trephine technique (16.7 percent versus 47.9 percent; p < 0.001). There was no significant difference in complication rates or length of admission between treatment groups. CONCLUSIONS: The use of corticocancellous block alveolar bone grafting demonstrated significantly higher success rates when compared to cancellous-only trephine techniques, with no difference in complication rates. Although this must be weighed against the minor disadvantages of open iliac harvest, surgeons should consider incorporating en bloc corticocancellous bone to optimize outcomes in alveolar bone grafting. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Palatoplasty Using Alveolar Ridge Incisions: A Novel Approach for Addressing Cleft Palate Deformities.

Background: Traditionally, plastic surgeons have performed palatoplasties using mucoperiosteal flaps with lateral incisions that are medial to the alveolar ridge. However, narrow flaps can cause limitations in some cases. To construct larger and wider flaps and minimize exposed bone after closure, we propose a novel technique that entails creating the lateral incisions at the top of the alveolar ridge, instead of the base of the alveolar ridge, to capture more tissue when repairing the hard palate. Methods: A retrospective chart review was conducted for patients undergoing cleft palate repair with the aforementioned technique. Information collected included basic demographic and diagnostic factors related to cleft palate deformity and history of previous facial surgeries. Operative report details and postoperative complications were analyzed. Results: Nineteen patients with hard palate clefts were included in the analysis, with the majority being women (68%). There was a balanced representation of patients with Veau classifications of II (47%) and III (42%). The majority of patients had an isolated cleft palate (74%) and incomplete deformity (63%), with no other craniofacial deformities. One (5%) had postoperative self-limited oronasal fistula managed conservatively. Conclusions: We present a novel approach for repairing cleft palate deformities by extending the lateral incision to the top of the alveolar ridge to create larger mucosal flaps. Further longitudinal studies are needed to evaluate how this unique approach compares to traditional methods-with respect to impact on maxillary growth processes, requirement for subsequent surgeries beyond two years of follow-up, and ultimately normalized speech over time.

Outcomes in Pediatric Maxillofacial Reconstruction With Vascularized Fibular Flaps: A Systematic Review.

BACKGROUND: The purpose of this study was to examine the complications and outcomes after maxillofacial reconstruction using the free fibular flap in the pediatric population. METHODS: A systematic review and descriptive analysis were conducted using data variables, including study characteristics; patient characteristics; postoperative complications (major and minor); surgical revision; and dental rehabilitation. RESULTS: The systematic review resulted in 1622 articles, 55 of which met inclusion criteria for this study. The 55 articles consisted of 17 case series and 38 case reports with level III/IV and level V of evidence, respectively. Of the 155 identified pediatric patients, the rate of major complications was 13.5% and minor complications was 24.5%. The most common complication was mild growth distortion (n = 7) at the recipient site. Complications at the donor site were less common. During follow-up, 29 patients (18.7%) underwent or awaited surgical revision, and 43 patients (27.7%) underwent or awaited dental rehabilitation. CONCLUSIONS: Our study suggests that the free fibular flap for pediatric maxillofacial reconstruction is safe and reliable. Additionally, surgical revision to correct the functional impairments resulting from primary reconstruction using the free fibular flap is relatively common.

The Impact of COVID-19 on the Personal Protective Equipment Practices and Preferences of Craniofacial Surgeons.

BACKGROUND: The COVID-19 pandemic has raised concern about healthcare worker exposure risk. Surgeons operating near the aerodigestive tract are at particularly high risk, given the respiratory spread of SARS-CoV-2. This study examines the practices and opinions of craniofacial surgeons as they adapt to a worldwide epidemic. METHODS: An electronic survey study was conducted on practicing craniomaxillofacial surgeons regarding their preference of personal protective equipment use before, during, and after the pandemic in patients with or without COVID-19 infection, as well as demographic data. Statistical analysis was performed to compare changes in behaviors and preferences and differences across demographic groups. RESULTS: Craniofacial surgeons changed their behaviors significantly during the pandemic, with 91.5% of respondents wearing N95 masks or powered air purifying respirators for operations involving exposure of the nasal or oral airways on untested patients, compared with 4.3% before the pandemic (P < 0.001). For examinations in the clinic, 100% reported wearing a mask during the pandemic compared with 40.3% before the pandemic (P < 0.001). After the pandemic is over, 31.9% of surgeons planned to continue using an N95 mask or powered air purifying respirator for craniomaxillofacial cases and 80.9% planned to continue using masks in clinic. Overall, 46.8% of respondents believed that N95 masks should be the standard for craniofacial surgery. CONCLUSIONS: The COVID-19 pandemic has significantly shifted the practices and opinion of craniofacial surgeons toward more protective personal protective equipment. These results indicate that this is likely to persist after the pandemic is over, which may limit surgeon exposure to airborne disease and help the field withstand future epidemic outbreaks.

Use of Resorbable Fixation System in Pediatric Facial Fractures.

INTRODUCTION: Resorbable fixation system (RFS) is an alternative to titanium in open reduction and internal fixation of pediatric facial fractures. METHODS: This study retrospectively reviewed all medical records in a major metropolitan pediatric hospital in Cape Town, South Africa from September 2010 through May 2014. Inclusion criteria were children under the age of 13 with facial fractures who have undergone open reduction and internal fixation using RFS. Intraoperative and postoperative complications were reviewed. RESULTS: A total of 21 patients were included in this study. Twelve were males and 9 were females. Good dental occlusion was achieved in all patients and there were no complications intraoperatively. Three patients developed postoperative implanted-related complications: all 3 patients developed malocclusions and 1 developed an additional sterile abscess over the right zygomatic bone. For the latter, incision and drainage was performed and the problem resolved without additional operations. DISCUSSION: Resorbable fixation system is an alternative to titanium products in the setting of pediatric facial fractures without complications involving delayed union or malunion. The combination of intermaxillary fixation and RFS is not needed postoperatively for adequate fixation of mandible fractures. Resorbable fixation system is able to provide adequate internal fixation when both low-stress and high-stress craniofacial fractures occur simultaneously.

Quantitative comparison of volume maintenance between inlay and onlay bone grafts in the craniofacial skeleton.

BACKGROUND: Nonvascularized autologous bone grafts are the criterion standard in craniofacial reconstruction for bony defects involving the craniofacial skeleton. The authors have previously demonstrated that graft microarchitecture is the major determinant of volume maintenance for both inlay and onlay bone grafts following transplantation. This study performs a head-to-head quantitative analysis of volume maintenance between inlay and onlay bone grafts in the craniofacial skeleton using a rabbit model to comparatively determine their resorptive kinetics over time. METHODS: Fifty rabbits were divided randomly into six experimental groups: 3-week inlay, 3-week onlay, 8-week inlay, 8-week onlay, 16-week inlay, and 16-week onlay. Cortical bone from the lateral mandible and both cortical and cancellous bone from the ilium were harvested from each animal and placed either in or on the cranium. All bone grafts underwent micro-computed tomographic analysis at 3, 8, and 16 weeks. RESULTS: All bone graft types in the inlay position increased their volume over time, with the greatest increase in endochondral cancellous bone. All bone graft types in the onlay position decreased their volume over time, with the greatest decrease in endochondral cancellous bone. Inlay bone grafts demonstrated increased volume compared with onlay bone grafts of identical embryologic origin and microarchitecture at all time points (p < 0.05). CONCLUSIONS: Inlay bone grafts, irrespective of their embryologic origin, consistently display less resorption over time compared with onlay bone grafts in the craniofacial skeleton. Both inlay and onlay bone grafts are driven by the local mechanical environment to recapitulate the recipient bed.

Reduction of rib fractures with a bioresorbable plating system: preliminary observations.

BACKGROUND: Operative fixation of rib fractures can reduce morbidity and mortality. Currently, resorbable fixation devices are used in a variety of surgical procedures. METHODS: A standard osteotomy was prepared in 30 New Zealand white rabbits at the 12th rib. Eighteen had surgical repair with bioresorbable plates and 12 underwent nonoperative management. Half the animals in each group were killed at 3-week postfracture and the remaining animals were killed at 6-week postfracture. Ribs were radiographed and processed histologically to assess fracture healing. Rib reduction was defined as the alignment of the rib ends in a structural condition similar to the prefractured state and quantitative radiomorphometry measured the radiopaque callus surrounding the rib injury sites. Statistical analysis was performed using Fisher's exact test and an unpaired Student's t test and significance was established at p < 0.05. RESULTS: At both the 3- and 6-week intervals, seven of the nine rib fractures remained reduced in the operative group, whereas zero of six and three of six of the rib fractures remained reduced, respectively, in the nonoperative group. A statistically significant increase in radiopaque callus surrounding the rib injury sites was observed at 3 and 6 weeks in the fixed groups. CONCLUSIONS: Fixation of rib fractures with a bioresorbable miniplate system was superior to nonoperative treatment at the 3-week interval, with a statistically significant increase in radiopaque callus formation at both 3 and 6 weeks. Additional studies will evaluate the biomechanical outcomes and degradation tissue response after extended in vivo intervals.

rhBMP-4 gene therapy in a juvenile canine alveolar defect model.

BACKGROUND: Autologous bone grafts have the disadvantages of donor-site pain and morbidity, finite supply, increased costs, and prolonged hospitalizations. Using a juvenile canine model, the authors hypothesized that recombinant human (rh) bone morphogenetic protein (BMP)-4 gene therapy-treated alveolar defects would promote bone healing and canine tooth eruption equal to their autografted counterparts. METHODS: Sixty-five maxillary alveolar defects were created in juvenile foxhound dogs with a mean age of 80.8 days. Nineteen defects were treated with DNA plasmid encoding rhBMP-4, 16 defects were autografted, 15 defects contained scaffold only, and 15 defects were left unrepaired. At 4 and 12 weeks after surgery, bone density and tooth eruption were measured, respectively. Data were subjected to one-way analysis of variance testing with statistical significance established at p < 0.05. RESULTS: At 4 weeks, the bone densities in the rhBMP-4, autografted, scaffold-only, and defect-only groups were 31.2 +/- 6.5, 30.5 +/- 8.1, 18.4 +/- 3.8, and 15.2 +/- 4.0 percent, respectively. A significant effect (p < 0.05) was observed between the rhBMP-4 gene therapy-treated and autografted groups compared with the scaffold-only and defect-only groups. At 12 weeks, the rates of tooth eruption measured in the rhBMP-4, autografted, scaffold-only, and defect-only groups were 67.4 +/- 15.8, 58.3 +/- 18.8, 52.7 +/- 16.2, and 45.0 +/- 13.3 percent, respectively. A significant effect (p < 0.05) was observed between the rhBMP-4 gene therapy-treated and defect-only groups. CONCLUSIONS: In the present studies, rhBMP-4 gene therapy was equivalent to autografting and superior to the scaffold-only and unrepaired defect in bone regeneration and tooth eruption. With decreased morbidity and cost, rhBMP-4 gene therapy may ultimately become an alternative to autografting to repair bony defects.

Comprehensive rhinoplasty technique to correct the bilateral cleft lip nasal deformity using conchal composite grafts.

INTRODUCTION: Anatomical abnormalities and heterogeneous tissue deficiencies of the bilateral cleft lip nasal deformity challenges the cranio-maxillofacial plastic surgeon to create a functional, yet aesthetically pleasing nose. The authors propose a comprehensive rhinoplasty technique to correct the bilateral cleft lip nasal deformity using composite conchal grafts. PATIENTS: Five children with bilateral cleft lip nasal deformities had nasal reconstruction using conchal composite grafts, averaging 5 years in age at time of surgery. Patient follow-up averaged 21 months. METHODS: An open tip rhinoplasty was performed using a 'V' shaped columellar incision. The conchal composite graft was obtained from the lateral aspect of the ear and was used to reconstruct the lateral alar mucosal defects. Conchal cartilage was used as a columellar strut. The columellar skin was closed in a 'V-Y' fashion, giving greater columellar length. RESULTS: Visual inspection confirmed that the cleft lip nasal deformity was improved in all patients. There were no postoperative complications. All patients had complete composite graft take with minimal donor site morbidity and deformity. CONCLUSIONS: This comprehensive rhinoplasty technique improves the abnormalities found in bilateral cleft lip nasal deformity by using the successful aspects of other methods and introducing the composite conchal graft.