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

Model Number PK622813

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2020

Event Type  malfunction  

Event Description

According to the reporter, during a cranioplasty procedure, the surgeon wanted to put the screws in the implant and it broke on the front side.The surgeon decided to use a long plate to repair.There was no injury to the patient.There was no delay in the surgery time.The back up implant was not used.The implant will not be returned as it remains implanted.No fragments from the fractured implant fell into the patient.

• Brand Name: HTR-PEKK
• Type of Device: CRANIAL IMPLANT
• Manufacturer (Section D): OXFORD PERFORMANCE MATERIALS; po box 585; 30 souh satelliet road; south windsor, ct
• Manufacturer (Section G): OXFORD PERFORMACE MATERIALS; 30 south satellite road; south windsor, ct
• Manufacturer Contact: beth pashko ; 30 south satellite road; south windsor, ct ; 6569450
• MDR Report Key: 9795029
• MDR Text Key: 202428773
• Report Number: 3009582362-2020-00004
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00081002392323
• UDI-Public: 0081002392323
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K121818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/05/2020

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?: Yes
• Device Operator: No Information
• Device Model Number: PK622813
• Device Lot Number: 207328
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 03/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2019
• 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