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

Model Number PK624903

Device Problem Crack (1135)

Patient Problem Fall (1848)

Event Date 08/02/2022

Event Type  malfunction  

Event Description

It was reported that after implantation, implant pk624903 was cracked due to the patient either falling or being struck.Exact dates of implantation and device fracture are not known.

• 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: 15242756
• MDR Text Key: 298080582
• Report Number: 3009582362-2022-00008
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810077244227
• UDI-Public: (01)00810077244227(10)211108
• 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: 08/09/2022

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
• Device Operator: Health Professional
• Device Model Number: PK624903
• Device Lot Number: 211108
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/02/2022
• Initial Date FDA Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• 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 Outcome(s): Other