inforMED
InjuryFWP

MEDPOR CUSTOMIZED CRANIAL-S

Received Mar 19, 2026 · Event occurred Feb 20, 2026

Report 0008010177-2026-00036 · MDR key 24638120

Device

Generic name

Implant

Catalog number

54440110

Lot number

2512311003

Product problems

  • Device Appears to Trigger Rejection

Patient

NA · Unknown

  • Unspecified Infection

Narrative

Additional Manufacturer Narrative

DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AFTER THE INITIAL SURGERY THAT LEAKED FROM THEIR EYE. DURING THE INVESTIGATION OF THE INFECTION, PART OF THE IMPLANT HAD TO BE REMOVED.