BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE GAMMA3 300X160MM

    MDR report key: 2760017 · Received September 20, 2012

    Report

    Report Number
    9610622-2012-00417
    Event Type
    Malfunction
    Date Received
    September 20, 2012
    Date of Event
    September 10, 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
    GM
    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.

    Description of Event or Problem · 1

    OUR EMPLOYEE REPORTED TO US THAT DURING A SURGERY, A MISS DRILLING HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET DEVICE GAMMA3 300X160MM INSTRUMENT HSB STRYKER OSTEOSYNTHESIS KIEL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other