MAUDE Adverse Event Report: SYNTHES USA; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: (b)(4).This report is for unknown peek/unknown quantity/unknown lot.The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Literature article received: this report is being filed after the subsequent review of the following literature article: alonso-rodriguez, e., et al (2015) polyetheretherketone custom-made implants for craniofacial defects: report of 14 cases and review of the literature.Journal of cranio-maxillo-facial surgery 43(2015)1232-1238.A retrospective review was conducted of 14 patients who underwent peek craniofacial reconstruction between 2008 and 2014.Over the 6 years, 14 patients (4 men and 10 women; mean age 42.7 years) underwent craniofacial reconstruction using a peek psi (polyetheretherketone- patient specific implant) due to defects arising from different pathologic conditions including trauma (1 patient), congenital deformities (4 craniofacial dysplasias and 1 facial cleft), and various benign and malignant tumors (8 cases).Postoperative complications were observed in five patients.One patient had a seroma, another patient had a cerebrospinal fluid (csf) leak that was treated conservatively, and two other patients presented with infection.In one of the patients with infection, the implant had to be removed, sterilized, and replaced during a single intervention.In the second infective case, the patient was treated with a 4 week course of antibiotics according to the antibiogram (vancomycin) leading to a full resolution of the symptoms.In a single case, inflammation of the frontal sinus was observed in follow-up imaging, but the patient was asymptomatic, and no treatment was deemed necessary.One wound dehiscence with implant exposure due to cutaneous necrosis was observed.This refers to: patient 3, female, age (b)(6): infection-implant removed and replaced.This is report 1 of 5 for (b)(4).This report is for unknown peek implants.

• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6252064
• MDR Text Key: 64884427
• Report Number: 2520274-2017-10152
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR