BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 95MM

    MDR report key: 3173622 · Received June 17, 2013

    Report

    Report Number
    2520274-2013-03460
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 21, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND A LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH TFN NAIL AND HELICAL BLADE ON (B)(6) 2013. ON (B)(6) 2013 THE CONSULTANT WAS ADVISED BY THE SURGEON THAT THE HELICAL BLADE HAD CUT OUT OF THE FEMORAL HEAD, AND THE PATIENT NEEDED REVISION SURGERY. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013; SURGEON REMOVED THE HELICAL BLADE AND REPLACED IT WITH AN 80MM TFN SCREW. THERE WAS NO INFORMATION CONCERNING THE PATIENT'S CONDITION FOLLOWING REVISION SURGERY. THIS IS REPORT 1 OF 1 FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274008 11.0MM TI HELICAL BLADE 95MM ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention