BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOLT Ø4.9 SELF-TAP L34 TAV GREEN

    MDR report key: 3480417 · Received November 21, 2013

    Report

    Report Number
    8030965-2013-05322
    Event Type
    Malfunction
    Date Received
    November 21, 2013
    Date of Event
    October 13, 2013
    Report Date
    October 31, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTY
    PMA / PMN Number
    K970733
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADD'L PRO CODES: JDW, JDS. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE PATIENT HAD AN INTERTROCHANTERIC FEMORAL FRACTURE AND AN ADVANCED DEMENTIA. PATIENT WAS IMPLANTED WITH PROXIMAL FEMORAL NAIL ANTIROTATION ON (B)(6) 2013. ABOUT SEVEN MONTHS OR SO LATER, APPROXIMATELY (B)(6) 2013, AFTER THE PFNA SURGERY, PATIENT FELL OFF THE BED AND WAS WOUNDED. THE FURTHER SURGERY WILL NOT BE PERFORMED DUE TO PATIENTS ADVANCED DEMENTIA. PATIENT NEEDS COMPLETE BED REST FOR PROLONGED PERIODS. THIS COMPLAINT IS ON THE BOLT SELF-TAPPING. THIS IS 3 OF 3 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606142 BOLT Ø4.9 SELF-TAP L34 TAV GREEN HTY SYNTHES GMBH 5920243

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female