BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI END CAP T25 STRDRV HINDFOOT

    MDR report key: 1855131 · Received September 30, 2010

    Report

    Report Number
    1719045-2010-00273
    Event Type
    Injury
    Date Received
    September 30, 2010
    Report Date
    September 13, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K051678
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS UNABLE TO PROVIDE THE DATE OF MANUFACTURE WITHOUT PRODUCT RETURNED AND/OR LOT NUMBER PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER, A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED.

    Description of Event or Problem · 1

    PT STATUS POST HIND FOOT ARTHRODESIS RETURNED TO SURGEON. AN X-RAY SHOWED THE SPIRAL BLADE BACKED OUT. SURGEON REMOVED THE SPIRAL BLADE AND END CAP AND REPLACED WITH ANOTHER BLADE AND END CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI END CAP T25 STRDRV HINDFOOT END CAPS HSB SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention SPIRAL BLADE