BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE CLAMP, TITANIUM

    MDR report key: 2485527 · Received March 7, 2012

    Report

    Report Number
    1723170-2012-00121
    Event Type
    Malfunction
    Date Received
    March 7, 2012
    Date of Event
    February 9, 2012
    Report Date
    February 9, 2012
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT DEMOGRAPHIC IS NOT AVAILABLE. ALL INFO IS THE SAME FOR DEVICE 1 AND DEVICE 2; EXCEPT LOT NUMBER OF DEVICE 2 IS: 110118. MANUFACTURE DATE FOR DEVICE 2 IS: 01/18/2011. DEVICE 1: THE CLAMP FACE IS SLIGHTLY BENT TO ONE SIDE AND THE TEETH ARE BENT. DEVICE 1 AND 2: THE ADJUSTMENT SCREW IS DAMAGED. THE HEAD OF THE SCREW HAS TOOL MARKS ALL AROUND AND SOME ROUNDING OUT INSIDE THE HEX HEAD. THE CLAMPS APPEAR TO HAVE BEEN REPEATEDLY OVERTIGHTENED.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT THEY HAVE TWO OPEN SPINE CLAMPS THAT HAVE BECOME STRIPPED AND NEED TO BE REPLACED. THIS HAD NO IMPACT ON ANY PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPEN SPINE CLAMP, TITANIUM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. NA 110727

    Patients

    Seq Age Sex Outcome Treatment
    1