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

Model Number	SD800.541
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/05/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• MDR Report Key: 6679631
• Report Number: 2530088-2017-10217
• Device Sequence Number: 220548
• Product Code: GXN
• UDI-Device Identifier: 10887587066004
• UDI-Public: (01)10887587066004(10)H372832
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K053199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SD800.541
• Device Catalogue Number: SD800.541
• Device Lot Number: H372832
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2017
• Initial Report FDA Received Date: 06/29/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention