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

Model Number	PK621416
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A piece of the implant broke off while the surgeon was trying to place the implant into the patient.The surgeon was able to put a screw through the piece that broke off to implant it into the patient separately.

• Brand Name: HTR-PEKK
• Common Device Name: FACIAL IMPLANT
• Manufacturer (Section D): OXFORD PERFORMANCE MATERIALS; po box 585; 30 south satellite road; south windsor CT 06074
• MDR Report Key: 8479206
• Report Number: 3009582362-2019-00005
• Device Sequence Number: 1471699
• Product Code: KKY
• UDI-Device Identifier: 00810042038134
• UDI-Public: 00810042038134
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K161052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2019

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
• Operator of Device: No Information
• Device Model Number: PK621416
• Device Lot Number: 204686
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/03/2019
• 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: Other
• Patient Age: 50 YR