BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM F/IM NAILS-STER

    MDR report key: 3192598 · Received June 27, 2013

    Report

    Report Number
    1719045-2013-01730
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    June 3, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K103002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE WAS IMPLANTED ON AN UNKNOWN DATE APPROXIMATELY ONE YEAR EARLIER. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH REPORT (B)(4) WAS RECEIVED. A COPY OF THE REPORT WILL BE INCLUDED IN THIS REPORT. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292439 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM F/IM NAILS-STER HSB SYNTHES MONUMENT 6616613

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention