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

Model Number PK624216

Device Problem Melted (1385)

Patient Problem Insufficient Information (4580)

Event Date 07/01/2021

Event Type  malfunction  

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 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
• 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: 12207381
• MDR Text Key: 264952270
• Report Number: 3009582362-2021-00009
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810077240212
• UDI-Public: (01)00810077240212(10)210311
• 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: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PK624216
• Device Lot Number: 210311
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2021
• 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: 73 YR