MAUDE Adverse Event Report: SYNTHES BRANDYWINE PSI SD800.541 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Model Number SD800.541

Device Problem Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 06/05/2017

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.Device was not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).No ncrs were generated during the production of the lot.Review of device history records found no relevant issues that would result in this complaint condition.Manufacture location: (b)(4).Manufacture date: 22-may-2017.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that a patient specific implant (psi) could not be used in surgery due to the implant not fitting properly.It was further explained that the psi was noted to fit on one side but not the other.The surgeon decided to cut the implant in half and go ahead and implant it in the patient as planned.There was an unknown surgical delay due to the change in the surgical plan and the adjustments required to make the psi fit.It is unknown what devices were used to cut the implant in half, what devices were used to assist with the fitting.Plates may have been used to span the middle of the psi but this has not been confirmed.To the reporter's knowledge, there was no harm to the patient.The surgeon is considering a revision but, to date, a revision surgery has not been scheduled.This report is for one (1) psi peek implant.This is report 1 of 1 for com-(b)(4).

• Brand Name: PSI SD800.541 PEEK IMPLANT
• Type of Device: PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6679631
• MDR Text Key: 78781706
• Report Number: 2530088-2017-10217
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 10887587066004
• UDI-Public: (01)10887587066004(10)H372832
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SD800.541
• Device Catalogue Number: SD800.541
• Device Lot Number: H372832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention