BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONY SLIDER

    MDR report key: 1031308 · Received April 18, 2008

    Report

    Report Number
    1649384-2008-00215
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Report Date
    April 18, 2008
    Manufacturer
    ABBOTT SPINE, INC.
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MALFUNCTION DID NOT HAPPEN DURING SURGERY. PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. REQUESTS HAVE BEEN MADE FOR THE RETURN OF THE PRODUCT. REQUEST HAS BEEN MADE TO OBTAIN THE PRODUCT. EVALUATION IS PENDING UPON THE RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    ON 21 MAR 2008, THE SALES REP REPORTED THAT IT WAS NOTICED THAT THE SET SCREW WAS MISSING FROM ONE SLIDERS THAT ATTACHES TO D-RING. ADDITIONAL INFO REPORTED ON THE FOLLOWING MONTH, VIA TELEPHONE, FROM THE SALES REP THAT ON AN UNK DATE, DURING AN INSPECTION OF THE KIT, IT WAS NOTICED THAT THE SET SCREW WAS MISSING ON THE SLIDER. THE MALFUNCTION IS LIKELY TO CAUSE PT INJURY IF IT WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONY SLIDER HARMONY GAD ABBOTT SPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1