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

Model Number PK620653

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 04/03/2018

Event Type  malfunction  

Event Description

The distributor reported while the surgeon was attempting to pre-plate the implant away from the patient, the implant fractured when the surgeon attempted to insert the screws.The distributor stated the surgeon did not pre-drill, and a manual driver was used.There was no injury.There was a delay of approximately 20 minutes while the patient's native bone flap was retrieved.The patient's native bone flap was used to complete the procedure.

• 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: 7475257
• MDR Text Key: 107592678
• Report Number: 3009582362-2018-00003
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810042032965
• UDI-Public: 00810042032965
• 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: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PK620653
• Device Lot Number: 201883-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/27/2017
• 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): Other
• Patient Age: 39 YR