BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM

    MDR report key: 3093282 · Received May 6, 2013

    Report

    Report Number
    2520274-2013-02343
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Report Date
    April 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K100776
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE: HWC. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BRAND NAME CORRECTED FROM SYNTHES TO 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM. MANUFACTURER NAME, CITY AND STATE WAS CORRECTED TO SYNTHES USA, (B)(4).

    Description of Event or Problem · 1

    A COPY OF THE USER FACILITY'S MEDWATCH REPORT WAS RECEIVED. THE USER FACILITY REPORT # IS NOT LISTED ON THE REPORT. A COPY OF THE USER FACILITY REPORT WILL BE INCLUDED IN THIS REPORT. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196367 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1