BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCOMPASS

    MDR report key: 1011347 · Received March 11, 2008

    Report

    Report Number
    1649384-2008-00120
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 8, 2008
    Report Date
    March 11, 2008
    Manufacturer
    ABBOTT SPINE, INC.
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUEST HAS BEEN MADE TO OBTAIN THE PRODUCT. DEVICE MFR DATE IS UNK. EVALUATION IS PENDING UPON THE RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    ON 13 FEB 2008, THE SALES REP REPORTED THAT THE MIDDLE SCREW WAS LOST. ADDITIONAL INFO RECEIVED ON 11 MAR 2008 VIA TELEPHONE: THE SALES REP REPORTED THAT DURING A LUMBAR FUSION SURGERY, THE SURGICAL TECH WENT TO GET THE SPEEDLINK WHEN SHE NOTICED ON THE BACK TABLE THAT THE MIDDLE SCREW WAS MISSING. THE SURGICAL TECH LOOKED FOR THE MISSING SCREW IN THE KIT AND IT WAS NOT FOUND. THE SURGEON FINISHED THE CASE AS INTENDED BY USING ANOTHER SPEEDLINK. THERE WAS NO REPORT OF PT INJURY OR SURGICAL DELAY. THIS MALFUNCTION, MISSING SET SCREW HAS RESULTED IN AN ADVERSE EVENT IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INCOMPASS SPEEDLINK ADJUST LENGTH TRANSVERSE CONNECTOR-SHORT KWP ABBOTT SPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK