BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI

    MDR report key: 15410083 · Received September 13, 2022

    Report

    Report Number
    15410083
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    August 9, 2022
    Report Date
    September 6, 2022
    Manufacturer
    STRYKER TRAUMA SA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MD WAS UNABLE TO COMPLETELY RETRIEVE 38MM SCREW WHEN SCREW BROKE OFF IN PATIENT IMPLANT. SEVERAL ATTEMPTS MADE. PATIENT WITH NO APPARENT STRESS AND VITAL SIGNS WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2579955 MINI SCREW, FIXATION, BONE HWC STRYKER TRAUMA SA IC3038

    Patients

    Seq Age Sex Outcome Treatment
    1 5475 DA Male