BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONY RETRACTOR SLIDERS (LONG SLIDER)

    MDR report key: 1231103 · Received October 30, 2008

    Report

    Report Number
    1649384-2008-00538
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 30, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    GAD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DID NOT OCCUR IN SURGERY. PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. REQUEST HAS BEEN MADE TO OBTAIN THE PRODUCT. EVALUATION IS PENDING, UPON RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    ON 06 OCT 2008, THE DISTRIBUTOR REPORTED THAT PRIOR TO SURGERY IN 2008, IT WAS IDENTIFIED THAT THE SCREW WAS LOOSE. IF THIS MALFUNCTION WERE TO RECUR IN SURGERY THERE IS A POTENTIAL FOR THE SCREW TO FALL INTO THE WOUND, RESULTING IN A SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONY RETRACTOR SLIDERS (LONG SLIDER) HARMONY GAD ABBOTT SPINE 40NK

    Patients

    Seq Age Sex Outcome Treatment
    1