BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5MM CANCELLOUS BONE SCREW 32MM THREAD/70MM

    MDR report key: 3121819 · Received May 21, 2013

    Report

    Report Number
    8030965-2013-02293
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    March 7, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K974537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE INVESTIGATION CARRIED OUT CONFIRMED THAT THE CONTENT DID NOT MATCH THE LABEL. THIS IS A PACKAGING ERROR WHICH WAS NOT DETECTED DURING THE FINAL QUALITY CONTROL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INCORRECT CONTENT WAS FOUND IN A PACKAGE. THERE WAS A DRILLED SCREW IN THE PACKAGING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224424 6.5MM CANCELLOUS BONE SCREW 32MM THREAD/70MM KTT SYNTHES GMBH 2602624

    Patients

    Seq Age Sex Outcome Treatment
    1