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

Model Number PK620375

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

Patient Problems Unspecified Infection (1930); Tissue Breakdown (2681)

Event Type  Injury  

Event Description

The distributor reported that the implant had been removed due to skin breakdown and a suspected infection.

• Brand Name: HTR-PEKK
• Type of Device: CRANIAL IMPLANT
• Manufacturer (Section D): OXFORD PERFORMANCE MATERIALS; po box 585; 30 south satellite road; south windsor CT 06074
• Manufacturer (Section G): OXFORD PERFORMANCE MATERIALS; po box 585; 30 south satellite road; south windsor CT 06074
• Manufacturer Contact: beth pashko ; po box 585; 30 south satellite road; south windsor, CT 06074 ; 8606569450
• MDR Report Key: 8043162
• MDR Text Key: 126303564
• Report Number: 3009582362-2018-00008
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810042031777
• UDI-Public: 00810042031777
• 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: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PK620375
• Device Lot Number: 201457-001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2018
• 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
• Patient Age: 83 YR