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

Model Number	PK624289
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/23/2021
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: CRANIAL IMPLANT
• Manufacturer (Section D): OXFORD PERFORMANCE MATERIALS, INC.; 30 south satellite road; south windsor CT 06074
• MDR Report Key: 12456668
• Report Number: 3009592362-2021-00010
• Device Sequence Number: 16494436
• Product Code: GXN
• UDI-Device Identifier: 00810077240588
• UDI-Public: (01)00810077240588(10)210384
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2021

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
• Operator of Device: Health Professional
• Device Model Number: PK624289
• Device Lot Number: 210384
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR