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

Model Number	PK626711
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient who received pk626711 developed an infection in the staples used to close the incision.The infection was believed to have spread into the implant site, so it was removed.The infection has been cleared and a replacement implant was requested.

• Brand Name: HTR-PEKK
• Common Device Name: CRANIAL IMPLANT
• Manufacturer (Section D): OXFORD PERFORMANCE MATERIALS, INC.; 30 south satellite rd.; south windsor CT 06074
• Manufacturer (Section G): OXFORD PERFORMANCE MATERIALS, INC.; 30 south satellite rd.; south windsor CT 06074
• Manufacturer Contact: james porteus ; 30 south satellite rd.; south windsor, CT 06074 ; 8606989300
• MDR Report Key: 21684709
• Report Number: 3009582362-2025-00001
• Device Sequence Number: 15761567
• Product Code: GXN
• UDI-Device Identifier: 00810128537247
• UDI-Public: (01)00810128537247(10)214893
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PK626711
• Device Lot Number: 214893
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 57 YR
• Patient Sex: Unknown