MAUDE Adverse Event Report: OXFORD PERFORMANCE MATERIALS, INC. HTR-PEKK; CRANIAL IMPLANT

Model Number PK624289

Device Problem Fitting Problem (2183)

Patient Problem Insufficient Information (4580)

Event Date 08/23/2021

Event Type  malfunction  

Event Description

It was reported that the surgeon experienced issues with the device fitting during surgery which required significant burring to achieve an adequate fit.A large portion of the posterior and inferior edges of the implant was removed intraoperatively.During plating, the implant cracked around the screw hole.Surgeon completed surgery with the device as-is.

• Brand Name: HTR-PEKK
• Type of Device: CRANIAL IMPLANT
• Manufacturer (Section D): OXFORD PERFORMANCE MATERIALS, INC.; 30 south satellite road; south windsor CT 06074
• Manufacturer (Section G): OXFORD PERFORMANCE MATERIALS, INC.; 30 south satellite road; south windsor CT 06074
• Manufacturer Contact: james porteus ; 30 south satellite road; south windsor, CT 06074 ; 8606569438
• MDR Report Key: 12456668
• MDR Text Key: 272144502
• Report Number: 3009592362-2021-00010
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810077240588
• UDI-Public: (01)00810077240588(10)210384
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PK624289
• Device Lot Number: 210384
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 29 YR