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

Model Number PK624272

Device Problem Decoupling (1145)

Patient Problem Insufficient Information (4580)

Event Date 06/17/2021

Event Type  malfunction  

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 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
• 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: 12207371
• MDR Text Key: 264952878
• Report Number: 3009582362-2021-00008
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810077240441
• UDI-Public: (01)00810077240441(10)210367
• 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: PK624272
• Device Lot Number: 210367
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• 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: 68 YR