BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE AO COUPLING ASNIS III HALL FITTING

    MDR report key: 2767826 · Received September 25, 2012

    Report

    Report Number
    9610622-2012-00420
    Event Type
    Malfunction
    Date Received
    September 25, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 10, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ADDITIONAL DEVICE: (B)(4) LAG SCREW STEP DRILL GAMMA3 ?10.5X495 MM LOT NO. K885173.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATTACHMENT IS STUCK IN THE DRILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARGE AO COUPLING ASNIS III HALL FITTING INSTRUMENT HSB STRYKER OSTEOSYNTHESIS KIEL NA U26243

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other