BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA BLADE PERF L95 SST

    MDR report key: 3072523 · Received April 23, 2013

    Report

    Report Number
    2520274-2013-02085
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    October 31, 2012
    Report Date
    March 25, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED WITH PFNA BLADE AND NAIL ON AN UNKNOWN DATE. REPORTEDLY THE PFNA BLADE ADVANCED INTO THE PATIENTS JOINT. NO FURTHER INFORMATION WAS PROVIDED. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175340 PFNA BLADE PERF L95 SST HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention