MAUDE Adverse Event Report: SYNTHES BRANDYWINE PSI SD800.544 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Catalog Number SD800.544

Device Problem Difficult to Insert (1316)

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

Event Date 04/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Device was not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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 Description

It was report that the patient had original surgery on unknown date for a stab wound to the head.On (b)(6) 2016 a computerized tomography (ct) scan was done of the patient¿s cranium in preparation for ordering a custom patient specific peek implant.The custom peek implant, four (4) matrixneuro straight plates and eight (8) 4.0mm screws were implanted on (b)(6) 2017 to repair the patients wound.During the procedure the surgeon was distressed that the custom peek implant was not accurate.Surgeon needed to make modifications by burrowing down the edges of the peek implant for proper fit in the cranium.An additional 15 minutes operating room time was added due to the remolding on the brim of the peek implant.Surgery was completed successfully.Patient is reported in stable condition.Concomitant medical products: matrixneuro straight plate (part number unknown, lot number unknown, quantity 4), 4mm screws (part number unknown, lot number unknown, quantity 8).This report is for one (1) patient specific peek implant.This is report 1 of 1 for (b)(4).

• Brand Name: PSI SD800.544 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: 6534120
• MDR Text Key: 74161781
• Report Number: 2530088-2017-10103
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.544
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/05/2017
• Initial Date FDA Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MATRICNEURO PLATE (PART AND LOT UNKNOWN, QTY 4); SCREW (PART AND LOT UNKNOWN, QTY 8)