inforMED
InjuryJEY

LEVEL ONE CMF

Received Apr 23, 2026 · Event occurred Mar 24, 2026

Report 1000525271-2026-00009 · MDR key 24972102

Device

Generic name

Screw

Model number

SEE H11

Lot number

SEE H11

Product problems

  • Osseointegration Problem

Patient

51 YR · Male

  • Insufficient Information

Narrative

Additional Manufacturer Narrative

POSSIBLE PRODUCTS IDENTIFIED: 25-860-07-91, LOT 33704706, 25-861-05-91, LOT 33573794.

Description of Event or Problem

IT WAS REPORTED THAT SCREWS SECURING BSSO PLATES WERE REMOVED EIGHT WEEKS AFTER IMPLANT FOR UNKNOWN REASONS AFTER PATIENT HAD ACHIEVED GOOD BONE CONSOLIDATION. THEY WERE NOT REPLACED.