BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.MUELLER BONE HOOK

    MDR report key: 13026022 · Received December 16, 2021

    Report

    Report Number
    MW5106136
    Event Type
    Injury
    Date Received
    December 16, 2021
    Date of Event
    December 14, 2021
    Report Date
    December 15, 2021
    Manufacturer
    V.MUELLER / CAREFUSION 2200, INC.
    Product Code
    KIK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BONE HOOK BROKE DURING TRIAL IMPLANT PORTION OF SURGERY AND DECISION WAS MADE BY SURGEON TO INTENTIONALLY LEAVE PIECE BEHIND TO PREVENT FURTHER DAMAGE. FDA SAFETY REPORT ID #:(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1921614 V.MUELLER BONE HOOK HOOK, BONE KIK V.MUELLER / CAREFUSION 2200, INC. A01-0S4080-002

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Other