MAUDE Adverse Event Report: SYNTHES BRANDYWINE PSI SD800.427 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Catalog Number SD800.427

Device Problem Fitting Problem (2183)

Patient Problem Sedation (2368)

Event Date 05/22/2015

Event Type  Injury  

Event Description

It was reported that there was an issue with the fit of patient specific implant (psi).The implant had to be burred roughly 6 mm around the orbit and the temporal region to make it fit to be implanted.There was a delay of 20 to 30 minutes in surgery.The surgery was completed with no further surgical intervention required.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device not reportedly explanted.Dhr review ¿ reviewed scanned documentation in the dhr for psi device sd800.427 (9800966).Documentation shows this device was manufactured, etched, inspected, cleaned and forward for plasma treatment as per model specifications supplied by cmf product development on 1 may 2015.No inconsistencies were found during these processes.There were no ncr¿s issued against this work order.There were no issues with raw material.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PSI SD800.427 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4838613
• MDR Text Key: 5945190
• Report Number: 2530088-2015-10474
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK053199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.427
• Device Lot Number: 9800966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention