MAUDE Adverse Event Report: SYNTHES BRANDYWINE PSI SD800.439 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED,NONALTERABLE

Catalog Number SD800.439

Device Problems Inadequacy of Device Shape and/or Size (1583); Material Distortion (2977)

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

Event Date 08/06/2015

Event Type  malfunction  

Manufacturer Narrative

This report is for one unknown psi peek implant/unknown lot number.Device is not expected to be returned for manufacturer review/investigation.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the service 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.

Event Description

Report from synthes europe reports an event in (b)(6) as follows: it was reported that the peek psi does not fit properly implant date is (b)(6) 2015.The surgeon had to customize the peek psi for finalize the surgery.A prolongation of the surgery was reported but exact time is unknown.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A lot number of ¿01¿ was provided by the reporter.The lot is invalid for the part number also reported.As a result, a review of the device history records could not be requested.It was previously reported that a service history review was requested.That information was reported in error.The device, which is an implant, is not a serviceable device and therefore would not have a service history.Device 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.

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.

• Brand Name: PSI SD800.439 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5033422
• MDR Text Key: 24221651
• Report Number: 2520274-2015-15507
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.439
• Device Lot Number: 01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1