BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI END CAP T25 STRDRV HINDFOOTARTHRO NAIL-EX SPIRAL BLADE

    MDR report key: 3173611 · Received June 17, 2013

    Report

    Report Number
    2520274-2013-03496
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 21, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    PMA / PMN Number
    K051678
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER

    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

    ON (B)(6) 2012, CANNULATED HIND FOOT ARTHRODESIS NAIL SURGERY WAS PERFORMED. ON AN UNKNOWN DATE, AN X-RAY REVEALED THAT THE SPIRAL BLADE HAD BACKED OUT. THEREFORE, ON (B)(6) 2013, THE PATIENT UNDERWENT REVISION SURGERY AND A LONGER SPIRAL BLADE WITH AN END CAP WAS IMPLANTED. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273815 TI END CAP T25 STRDRV HINDFOOTARTHRO NAIL-EX SPIRAL BLADE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention