inforMED
MalfunctionHWM

NA

Received Jan 28, 2026 · Event occurred Jan 13, 2026

Report 24198728 · MDR key 24198728

Device

Generic name

Osteotome

Model number

2421-03-000

Catalog number

242103000

Lot number

(10) S02043834

Patient

68 YR · Female

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

OSTEOTOME - HAD BROKEN DURING SURGERY AND WAS LOCATED WITHIN THE SURGICAL FIELD, WITH ALL FRAGMENTS ACCOUNTED FOR.