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

Model Number PK618278

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

Patient Problem Unspecified Infection (1930)

Event Date 09/28/2016

Event Type  No Answer Provided  

Event Description

The implant was removed due to an infection.The cause or the source of the infection are unknown.The implant is shipped non-sterile and then sterilized at the healthcare facility according to the instructions for use.There are no sterilization, pathology, or surgical records available.

• Brand Name: HTR-PEKK
• Type of Device: CRANIAL IMPLANT
• Manufacturer (Section D): OXFORD PERFORMANCE MATERIALS, INC.; p.o. box 585; 30 south satellite road; south windsor CT 06074
• Manufacturer (Section G): OXFORD PERFORMANCE MATERIALS, INC.; p.o. box 585; 30 south satellite road; south windsor CT 06074
• Manufacturer Contact: leigh ayres ; p.o. box 585; 30 south satellite road; south windsor, CT 06074 ; 8606989300
• MDR Report Key: 6254490
• MDR Text Key: 64913899
• Report Number: 3009582362-2016-00001
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00813298024012
• UDI-Public: 00813298024012
• 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: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PK618278
• Device Lot Number: IG5865M-12F001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2016
• Initial Date FDA Received: 01/16/2017
• Date Device Manufactured: 07/13/2016
• 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): Required Intervention
• Patient Age: 50 YR