BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE RECESS 42MM

    MDR report key: 2895187 · Received January 3, 2013

    Report

    Report Number
    1719045-2013-00012
    Event Type
    Injury
    Date Received
    January 3, 2013
    Report Date
    December 5, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KTT
    PMA / PMN Number
    K000684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: 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. IMPLANT DATE UNKNOWN.

    Description of Event or Problem · 1

    DURING A SURGERY ON (B)(6) 2012 TO TREAT MEDIAL DISTAL TIBIA INFECTION, HARDWARE WAS REMOVED. HARDWARE WAS ORIGINALLY IMPLANTED TO TREAT A FRACTURE, WAS REMOVED SUCCESSFULLY. THIS IS 6 OF 7 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2889 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE RECESS 42MM SCREW KTT SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention PLATES, SCREWS