MAUDE Adverse Event Report: SYNTHES BRANDYWINE PSI SD800.411; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Catalog Number SD800.411

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It was reported that there was a revision cranioplasty and peek implant removal on (b)(6), 2014 due to patient pain.The patient had three peek implants inserted on a cranioplasty procedure on (b)(6), 2013.The patient came in approximately six to eight weeks ago complaining of pain from the right-side implant.The surgeon took a computerized tomography (ct) scan and did not see anything wrong with the implants, but decided to take all the implants, plates, and screws out to see if it would alleviate the pain issue.The explant procedure was complete successfully and it was noted that the fixation of the implants seemed stable and surgeon removed devices easily.The patient is doing well.There was no delay in surgery time.This is report 3 of 16 for (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.Pt weight: weight reported as (b)(6).Date of event: unknown 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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.A review of the device history records was performed and no complaint related issues were found.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PSI SD800.411
• 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: 3738169
• MDR Text Key: 4311788
• Report Number: 2530088-2014-10053
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SD800.411
• Device Lot Number: 7410340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2014
• Initial Date FDA Received: 04/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/07/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 39