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

Model Number PK623204

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

Patient Problem Impaired Healing (2378)

Event Date 06/03/2020

Event Type  Injury  

Event Description

Implant was implanted and subsequently removed 5 days after surgery as patient developed skin wound healing problems.

• Brand Name: HTR-PEKK
• Type of Device: CRANIAL IMPLANT
• Manufacturer (Section D): OXFORD PERFORMANCE MATERIALS, INC.; 30 south satellite road; south windsor, ct
• Manufacturer (Section G): OXFORD PERFORMANE MATERIALS, INC.; 30 south satellite road; south windsor, ct
• Manufacturer Contact: james porteus ; 30 south satellite road; south windsor, ct ; 6569438
• MDR Report Key: 10314735
• MDR Text Key: 200417217
• Report Number: 3009582362-2020-00006
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810023925071
• UDI-Public: 00810023925071
• 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: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PK623204
• Device Lot Number: 208694
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/09/2020
• 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 Outcome(s): Other