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

Model Number	PK624272
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device met all established safety and performance requirements prior to release.Placement of screw holes described by the initial reporter is closer to the edge than advised in the device instructions for use (ifu).In addition, ifu instructs users to pre-drill holes.The device remains implanted, so further evaluation is not possible.
Event or Problem Description
It was reported that the surgeon had issues with the 3.5mm thick implant.Surgeon attempted to place a fixation device without predrilling approximately 4-5mm from the edge and the implant cracked and a section of the implant chipped off.Surgeon predrilled remaining screw holes but one screw hole still resulted in a hairline crack when the screw was tighted all the way down.Surgeon was gentle in placing device and securing hardware and surgery was ultimately completed 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: 12207371
• Report Number: 3009582362-2021-00008
• Device Sequence Number: 16854002
• Product Code: GXN
• UDI-Device Identifier: 00810077240441
• UDI-Public: (01)00810077240441(10)210367
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 07/21/2021

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: PK624272
• Device Lot Number: 210367
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR