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

Catalog Number SD800.440

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: (b)(4).Incident occurred during the procedure.Device was not explanted.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 reported that on (b)(6) 2016, patient underwent a craniotomy procedure.During the procedure, the custom made cranial implant - peek psi - was too large, it had too much material.The surgeon had to cut the implant to fit properly.This caused a 30 minute delay in surgery.There was no report of patient harm and patient was stable.This report is for one (1) patient specific implant (psi peek implant).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device history record (dhr) review was performed on part #: sd800.440, lot #: h238754: manufacturing location: (b)(4), manufacturing date: 17-nov-2016: no non conformance reports (ncrs) were generated during production.The dhr review found no relevant issues that would result in this product complaint.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 SD800.440 PEEK IMPLANT
• Type of Device: PLATE, CRANIIOPLASTY, 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: 6219905
• MDR Text Key: 63800690
• Report Number: 2520274-2017-10014
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: SD800.440
• Device Lot Number: H238754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10 YR