BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-02795

    MDR report key: 3123623 · Received May 22, 2013

    Report

    Report Number
    2520274-2013-02795
    Event Type
    Injury
    Date Received
    May 22, 2013
    Report Date
    April 24, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON AN UNKNOWN DATE, A PATIENT UNDERWENT SURGERY AND WAS IMPLANTED WITH A HINDFOOT ARTHRODESIS NAIL. THE PATIENT WAS TAKEN BACK TO THE OPERATING THEATRE AS THE SPIRAL BLADE HAD BACKED OUT. IT WAS REPLACED WITH A NEW SPIRAL BLADE AND A LOCKING END CAP. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN UNKNOWN HINDFOOT NAIL. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225990 HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention