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

Model Number PK619467

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 10/02/2017

Event Type  Injury  

Event Description

The implant was removed due to an infection.The sales associate stated the patient has a thick scalp & the surgeon had difficulty stretching the skin over the implant, which the surgeon believes may have contributed to the issue.There is no known history of infection at the hospital and the sterilization records are not available.The type and cause/source of the infection are unknown.The implant was discarded after removal.

• 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, INC.; 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: 7000400
• MDR Text Key: 91008975
• Report Number: 3009582362-2017-00006
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00813298028041
• UDI-Public: 00813298028041
• 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: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PK619467
• Device Lot Number: IG7314M-15F001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/16/2017
• 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): Life Threatening
• Patient Age: 57 YR