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

Model Number PK625635

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

The case sales rep informed opm that the implant had to be explanted due to an infection in the patient.The rep confirmed that the infection was due to patient non-compliance.The surgeon requested an exact replica of the initial implant as a replacement.Implantation and explantation dates 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: 16499649
• MDR Text Key: 310853762
• Report Number: 3009582362-2023-00003
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810077248515
• UDI-Public: (01)00810077248515(10)211978
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180064
• 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: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PK625635
• Device Lot Number: 211978
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2022
• 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