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

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

Patient Problems Cerebrospinal Fluid Leakage (1772); No Code Available (3191)

Event Date 07/08/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment not diagnosis.Additional narrative: this report is for unknown polyetheretherketone (peek) patient-specific prostheses.(other number) udi: unknown part number, udi is unavailable.Investigation could not be completed and no conclusion could be drawn, as no devices were returned and no lot numbers or part numbers were provided.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the subsequent review of the following journal article: gerbino, g, et al.(2015) primary and secondary reconstruction of complex craniofacial defects using polyetheretherketone custom-made implants.Journal of cranio-maxillo-facial surgery, vol.43, pp: 1356-1363.The aim of this study was to evaluate the surgical outcomes using polyetheretherketone (peek) patient-specific prostheses (synthes, (b)(4)) produced by computer-aided design and manufacturing for primary and secondary reconstruction in patients with craniofacial defects.From june 2010 through june 2013, a total of 16 consecutive patients underwent cranio-orbital reconstruction with a follow-up period of at least 18 months.In patient 7, the resection involved the lateral aspect of the frontal sinus, which was preserved and sealed with a pericranial flap.On postoperative day 7, a cerebrospinal fluid leak was noted, and the patient underwent a second surgical intervention.The duroplasty needed to be revised.This report is for unknown polyetheretherketone (peek) patient-specific prostheses.A copy of the literature article is attached to the medwatch.This report is 1 of 1 for com-(b)(4).

• 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: 6217801
• MDR Text Key: 63704230
• Report Number: 2520274-2017-10000
• 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: 01/03/2017
• 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: 46 YR