BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE CLAMP, TITANIUM

    MDR report key: 3241415 · Received July 22, 2013

    Report

    Report Number
    1723170-2013-00539
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. RMA ISSUED. REPLACEMENT OPEN SPINE CLAMP SHIPPED TO SITE (B)(6) 2013. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT DEVICE FINDS THE ADJUSTMENT SCREW THREADS ARE DAMAGED IN MID-TRAVEL NOT ALLOWING THE CLAMP FACE TO MOVE BEYOND THIS AREA. THE THREADS ARE WORN DOWN AS WELL AS SOME DEBRIS IN THE THREADS. THIS MECHANICAL FAILURE, DEFORMATION, DIRECTLY CAUSED THE EVENT.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE (PURCHASING) REPORTED A STRIPPED SCREW ON THEIR OPEN SPINE CLAMP. THIS WAS IDENTIFIED OUTSIDE OF SURGERY. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340860 OPEN SPINE CLAMP, TITANIUM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 120118

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability