MAUDE Adverse Event Report: SYNTHES BRANDYWINE PSI SD800.445 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Catalog Number	SD800.445
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient age or date of birth, gender, and weight are not available for reporting.Date of infection is not known.Date of implant and date of explant is not known.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.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint action.Manufacturing site: (b)(4).Manufacturing date: 11-nov-2016.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 a patient specific implant (psi) peek implant, as well as the supporting unknown plate and screws, were explanted due to infection.Date of implant and date of explant are not known.It is unknown if there was any delay in surgery.Procedure was successfully completed.No x-rays were taken.This report is for one (1) psi peek implant.This is report 1 of 3 for (b)(4).

• Brand Name: PSI SD800.445 PEEK IMPLANT
• Common Device Name: PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• MDR Report Key: 6649769
• Report Number: 2530088-2017-10200
• Device Sequence Number: 16465069
• Product Code: GXN
• UDI-Device Identifier: 10887587065168
• UDI-Public: (01)10887587065168(17)H232238
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K053199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/23/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SD800.445
• Device Lot Number: H232238
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2017
• Initial Report FDA Received Date: 06/19/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention