BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KMEDIC LAMBOTTE OSTEOTOME

    MDR report key: 24712127 · Received March 30, 2026

    Report

    Report Number
    MW5186078
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    March 18, 2026
    Report Date
    March 24, 2026
    Manufacturer
    TELEFLEX LLC (NADC)
    Product Code
    GFI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TIP OF OSTEOTOME BROKE OFF INSIDE THE PATIENT WHILE THE SURGEON WAS USING A MALLET TO HIT IT. ALL PIECES WERE RETRIEVED. NO HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770982 KMEDIC LAMBOTTE OSTEOTOME OSTEOTOME, MANUAL GFI TELEFLEX LLC (NADC) 46-304

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention