MAUDE Adverse Event Report: OXFORD PERFORMANCE MATERIALS HTR-PEKK; POLYTETRAFLUOROETHYLENE (PTFE) WITH CARBON FIBERS

Model Number	PK618755-A
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	05/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Not returned from distributor.
Event or Problem Description
A revision (explantation) was required due to exposure of the plate through the tissue.The initial implantation of the implant was good, but over time, it the skin of the patient separated, and the implant was visable through the separation.

• Brand Name: HTR-PEKK
• Common Device Name: POLYTETRAFLUOROETHYLENE (PTFE) WITH CARBON FIBERS
• Manufacturer (Section D): OXFORD PERFORMANCE MATERIALS; po box 585; 30 south satellite road; south windsor CT 06074
• MDR Report Key: 6641329
• Report Number: 3009582362-2017-00004
• Device Sequence Number: 602475
• Product Code: KKY
• UDI-Device Identifier: 00813298025637
• UDI-Public: 00813298025637
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: PK618755-A
• Device Lot Number: IG6481M-12F001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2017
• Initial Report FDA Received Date: 06/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 67 YR