BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI TRANSCONNECTOR 75MM

    MDR report key: 3072267 · Received February 19, 2013

    Report

    Report Number
    2530088-2013-10374
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL LOT NUMBER, 6171349, WAS US LOT. LOT NUMBER RECEIVED ONCE DEVICE WAS REPACKAGED AT (B)(4). A REVIEW OF THE MANUFACTURING RECORD HAS BEEN REQUESTED. DEVICE WAS RETURNED (B)(4) 2010, NOT AVAILABLE FOR EVAL AT THIS TIME. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    (B)(4) CENTER OF SYNTHES (B)(6) INFORMED SYNTHES PRODUCT SERVICE, (B)(6), THAT MULTIPLE UNOPENED TRANSVERSE AND TRANSCONNECTORS WERE FOUND ON INCOMING INSPECTION TO HAVE THE SCREWS COMPLETELY SEPARATED FROM THE DEVICES INSIDE THE PACKAGES. THIS IS 2 OF 6 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73213 TI TRANSCONNECTOR 75MM KWP SYNTHES BRANDYWINE 3117373

    Patients

    Seq Age Sex Outcome Treatment
    1