MAUDE Adverse Event Report: SYNTHES BRANDYWINE PSI SD800.441 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

Catalog Number SD800.441

Device Problem Compatibility Problem (2960)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/30/2014

Event Type  malfunction  

Event Description

It was reported that a custom polyetheretherketone (peek) implant was not the correct size.The surgeon was performing a cranioplasty procedure and it was discovered that the implant was the incorrect size.The surgeon cut the plate to the correct size.There were no reports of a surgical delay.This report is 1 of 1 for complaint (b)(4).

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A review of the device history records for psi item (b)(4), lot #7681870, determined that this implant was produced to comply with the device specifications, and was produced from the correct raw material, as listed on both the psi router / inspection sheet (f-s315) and the brandywine routing.All packaging and labeling complied with the labeling and packaging presentation form (lppf), as indicated on the packaging label log (f-s252), there were no non-conforming reports (ncr) on this lot number.{no ncr's associated with the raw material lot number (7556237).} if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PSI SD800.441 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: 3965017
• MDR Text Key: 20107319
• Report Number: 2530088-2014-10194
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK033868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.441
• Device Lot Number: 7681870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23 YR