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

Model Number PK623206

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 08/31/2020

Event Type  Injury  

Event Description

Implant was reordered and it was indicated that the first implant was removed due to a possible infection.

• 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 PERFORMANE 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: 10508475
• MDR Text Key: 206157476
• Report Number: 3009582362-2020-00010
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810023924968
• UDI-Public: 00810023924968
• 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: Other
• Type of Report: Initial
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PK623206
• Device Lot Number: 208680
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2020
• 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: 27 YR