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

Model Number PK619160

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2017

Event Type  malfunction  

Manufacturer Narrative

Device was implanted.

Event Description

The implant chipped at the edge during insertion of a screw.The surgeon was attempting to fixate a plate (1.5.6 hole reg double ) with a 4 mm screw and a "sliver" of the implant (approximately 4 mm by 16 mm) broke off.This occurred away from the patient and did not cause any injury or delay in the case.A different plate (1.5 2.3 hole rectangle) was used and the part was successfully implanted.There is no revision planned.

• Brand Name: HTR-PEKK
• Type of Device: CRANIAL IMPLANT
• Manufacturer (Section D): OXFORD PERFORMANCE MATERIALS, INC.; po box 585; 30 south satellite road; south windsor CT 06074
• Manufacturer (Section G): OXFORD PERFORMANCE MATERIAL, INC; p.o. box 585; 30 south satellite road; south windsor CT 06074
• Manufacturer Contact: beth pashko ; p.o. box 585; 30 south satellite road; south windsor, CT 06074 ; 8606989300
• MDR Report Key: 6461308
• MDR Text Key: 72194708
• Report Number: 3009582362-2017-00002
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00813298026719
• UDI-Public: 00813298026719
• 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: 04/05/2017

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: PK619160
• Device Lot Number: IG6906M-10F001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2017
• Initial Date FDA Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2017
• 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 Age: 53 YR