MAUDE Adverse Event Report: SYNTHES BRANDYWINE PSI SD800.440 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Catalog Number	SD800.440
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient date of birth and weight are not available for reporting.Device is not expected to be returned for manufacturer review/investigation.Patient code used to capture additional medical/surgical intervention required.Device history records review was completed for part# sd800.440, lot# h049745.Manufacturing location: (b)(4), manufacturing date: feb 26, 2016.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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) had to be explanted due to infection.Patient will be revised to another patient specific implant (psi), but revision date has not been scheduled yet.This report is for one (1) patient specific implant (psi) sd800.440 peek implant.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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
Additional information was received on february 13, 2017 further reporting that the patient underwent hardware explant surgery on (b)(6) 2017 due to infection.A cranial patient specific implant (psi), three (3) titanium straight plates, and six (6) 4 mm titanium self-drilling screws where initially implanted on (b)(6) 2016 and were all removed during the (b)(6) 2017 surgery.The patient will undergo surgery to implant a new psi and associated hardware on an unknown future date.This report is 1 of 10 for (b)(4).

• Brand Name: PSI SD800.440 PEEK IMPLANT
• Common Device Name: PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• MDR Report Key: 6294191
• Report Number: 2530088-2017-10032
• Device Sequence Number: 543660
• Product Code: GXN
• UDI-Device Identifier: 10887587065113
• UDI-Public: (01)10887587065113(10)H049745
• 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
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2017

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: SD800.440
• Device Lot Number: H049745
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/01/2017
• Supplement Report FDA Received Date: 03/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention