BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT-STER

    MDR report key: 2852081 · Received November 30, 2012

    Report

    Report Number
    1719045-2012-01214
    Event Type
    Injury
    Date Received
    November 30, 2012
    Report Date
    November 3, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES.

    Description of Event or Problem · 1

    (B)(6) 2012 FOR REMOVAL OF HARDWARE. IT WAS REPORTED THAT THERE WAS A MEDIAL MIGRATION OF THE HELICAL BLADE DUE TO AVASCULAR NECROSIS. PATIENT WAS REVISED TO A TOTAL HIP REPLACEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THIS IS 1 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT-STER NAIL HSB SYNTHES MONUMENT 6603782

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention HELICAL BLADE, LOCKING SCREW