BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADJ. X-CONN. MEDIUM 45-60.5MM

    MDR report key: 2903741 · Received January 4, 2013

    Report

    Report Number
    3004608878-2012-00246
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    NKB
    PMA / PMN Number
    K091266
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THIS IS THE FIRST OF TWO REPORTS (SAME PT, SAME SURGERY, SAME PRODUCT, DIFFERENT LOT NUMBERS). IT WAS REPORTED THAT THE CROSS LINKS BROKE DURING INSTALLATION AND THE SECOND MEDIUM CROSSLINK ALSO BROKE, SO A SMALLER SIZE WAS USED. BOTH OF THE 10-22-0102 WERE USED FOR THE SAME SURGERY. THE DISTRIBUTOR DID NOT KNOW WHICH LOT OF 10-22-0102 WAS USED FIRST. THE PT WAS A (B)(6) FEMALE PT WHO UNDERWENT TLIF (TRANSFORAMINAL LUMBER INTERBODY FUSION). THERE WAS NO DELAY IN SURGERY AND THE PT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5246 ADJ. X-CONN. MEDIUM 45-60.5MM NONE NKB INTEGRA LIFESCIENCES CORPORATION OH/USA W4388

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR