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

Model Number PK621909

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The implant cracked during surgery, but the surgeon still implanted the device.There was no delay in surgery.

• 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: 8609308
• MDR Text Key: 145113803
• Report Number: 3009582362-2019-00007
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810042038738
• UDI-Public: 00810042038738
• 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: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PK621909
• Device Lot Number: 204991
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/28/2019
• 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: 63 YR