InjuryKKY
HTR-PEKK
Received Nov 18, 2024
Report 3009582362-2024-00008 · MDR key 20714254
Device
Generic name
Facial Implant
Manufacturer
Oxford Performance Materials, Inc.Model number
PK626175Lot number
212903
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Unspecified Infection
- Unspecified Infection
Narrative
Description of Event or Problem
SURGEON REPORTED TO OPM THAT THE PATIENT WHO RECEIVED FACIAL IMPLANT PK626175 DEVELOPED AN INFECTION. A REPLACEMENT WAS REQUESTED AND IS BEING DESIGNED UNDER A NEW PART NUMBER.
Remedial action
- Replace