InjuryGXN
HTR-PEKK
Received Jun 29, 2026
Report 3009582362-2026-00003 · MDR key 25660874
Device
Generic name
Cranial Implant
Manufacturer
Oxford Performance Materials, Inc.Model number
PK627301Lot number
220343
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
34 YR · Unknown
- Unspecified Infection
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WHO RECEIVED PK627301 DEVELOPED A POST-OPERATIVE INFECTION AND THE DEVICE WILL BE REMOVED. A REPLACEMENT DEVICE WAS REQUESTED.
Remedial action
- Replace