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

Catalog Number SD800.440

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

Patient Problem Reaction (2414)

Event Date 02/09/2015

Event Type  Injury  

Event Description

It was reported that the patients custom patient specific implant polyetheretherketone (psi peek) implant was uneventfully placed by surgeon.Patient was discharged to the post-anesthesia care unit (pacu).The patient returned to operating room with increased intracranial pressure and implant was removed.The procedure was completed successfully.There were no reports of a surgical delay this report is 1 of 19 for complaint com-(b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

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 SD800.440 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: 4536516
• MDR Text Key: 15319937
• Report Number: 2530088-2015-10074
• 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: 02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SD800.440
• Device Lot Number: 7909710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 61