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

Model Number	PK624216
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device met all established safety and performance requirements prior to release.Modification of the device in the manner described and for the purpose described by the initial reporter is outside of the intended use of the device.Opm was not able to obtain any more detail on the drill used by the surgeon.Further evaluation of the implant is not possible as the device was and remains implanted.
Event or Problem Description
It was reported that the implant material melted when the surgeon attempted to drill convergent holes into the implant to tack down the temporalis muscle.Reporter noted the drill was medtronic brand and had a large diameter - "almost a burr size" - and that the congealing closed the holes the surgeon had just drilled and the surgeon had to re-drill several times delicately so this wouldn't happen.Device remains implanted.

• 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: 12207381
• Report Number: 3009582362-2021-00009
• Device Sequence Number: 2839788
• Product Code: GXN
• UDI-Device Identifier: 00810077240212
• UDI-Public: (01)00810077240212(10)210311
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: PK624216
• Device Lot Number: 210311
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2021
• 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: 73 YR