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

Model Number	PK620905
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The sales rep reported that there was an infection approximately 1 week post-op.The patient was treated with antibiotics and the infection has resolved.There is no revision planned.No sterilization records are available.There is no known history of infection at the facility.This is report 2 of 2, as two separate devices were implanted at the same time.

• 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: 7704867
• Report Number: 3009582362-2018-00005
• Device Sequence Number: 2541512
• Product Code: KKY
• UDI-Device Identifier: 00810042034082
• UDI-Public: 00810042034082
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K161052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/19/2018

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: PK620905
• Device Lot Number: 202446-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 07/19/2018
• 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: 30 YR