BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONNECTOR HEAD TO HEAD - 48 MM

    MDR report key: 1728851 · Received June 8, 2010

    Report

    Report Number
    1530901-2010-00015
    Event Type
    Other
    Date Received
    June 8, 2010
    Date of Event
    May 3, 2010
    Report Date
    June 8, 2010
    Manufacturer
    THEKEN SPINE
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN EVALUATED. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A C2-C7 LEVEL SPINAL FUSION PROCEDURE USING THE ATOLL OCCIPITO-CERVICO-THORACIC FUSION SYSTEM. THE HEAD TO HEAD CROSS-LINK , PART # 16-22-1048 (HEAD TO HEAD CROSS CONNECTOR 48MM) WOULD NOT INSERT CORRECTLY. UPON ATTEMPTING TO TIGHTEN THE CROSS LINK SET SCREWS AT THE LEFT C4 LEVEL, THE SMALLER SIDE-TAB, WHICH HOLDS ONTO THE SCREW HEAD, APPEARED BENT AND NO LONGER ALLOWED A TIGHT FIT TO THE SCREW HEAD. THIS ALSO OCCURRED WITH THE LARGER SIDE TAB ON PART # 16-22-1041 (HEAD TO HEAD CROSS CONNECTOR 41MM). THE SURGEON DECIDED TO USE NO CROSS LINK. THERE WAS NO INJURY TO THE PT, HOWEVER, SURGERY TIME WAS EXTENDED BY APPROXIMATELY ONE HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONNECTOR HEAD TO HEAD - 48 MM ATOLL KWP THEKEN SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other