BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA 130 DEGREE NAIL 200L

    MDR report key: 2162143 · Received July 7, 2011

    Report

    Report Number
    8030965-2011-00307
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    February 8, 2011
    Report Date
    June 21, 2011
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    KTT
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO PROVIDE THE PMA/510K NUMBER AND/OR THE DATE OF MANUFACTURE. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM WALDENBURG INDICATES A CLINIC IN (B)(6) REPORTED: PATIENT STATUS POST PFNA 130 DEGREES NAIL IMPLANTATION ON (B)(6) 2010 HAD X-RAYS TAKEN ON AN UNKNOWN DATE THAT SHOWED THE NAIL WAS BROKEN AT THE HOLE OF THE LOCKING SCREW. MEDICAL / SURGICAL INTERVENTION WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFNA 130 DEGREE NAIL 200L PFNA 300 DEGREE NAIL KTT SYNTHES BETTLACH NA 2655097

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention SCREW