BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM TI TRANSVERSE BAR

    MDR report key: 2976854 · Received February 19, 2013

    Report

    Report Number
    2530088-2013-10031
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    January 25, 2010
    Report Date
    January 25, 2010
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    KWP
    PMA / PMN Number
    K091689
    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. ANY ADD'L INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE ORIGINAL LOT NUMBER, 6185722, WAS U.S. LOT # RECEIVED ONCE DEVICE WAS REPACKAGED AT (B)(4) IS 3233268. DEVICE RECEIVED IN (B)(4) 2010, NOT AVAILABLE AT THIS TIME. A REVIEW OF THE MFG RECORD HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    (B)(4) OF SYNTHES (B)(4) INFORMED SYNTHES PRODUCT SERVICE, (B)(4), THAT MULTIPLE UNOPENED TRANSVERSE BARS AND TRANSCONNECTORS WERE FOUND ON INCOMING INSPECTION TO HAVE THE SCREWS COMPLETELY SEPARATED FROM THE DEVICES INSIDE THE PACKAGES. THIS IS 7 OF 10 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72810 3.5MM TI TRANSVERSE BAR KWP SYNTHES BRANDYWINE 3233268

    Patients

    Seq Age Sex Outcome Treatment
    1