BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE CLAMP, TITANIUM

    MDR report key: 3648374 · Received February 26, 2014

    Report

    Report Number
    1723170-2014-00185
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Date of Event
    January 13, 2014
    Report Date
    January 29, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. LOT NUMBERS FOR 2 OPEN SPINE CLAMPS ARE 120726 AND 120301. DEVICE MANUFACTURE DATES FOR 2 OPEN SPINE CLAMPS ARE LOT #120726 ON 07/26/2012 AND LOT #120301 ON 03/01/2012. RMA ISSUED. 2 REPLACEMENT SPINE CLAMPS SHIPPED TO SITE 01/24/2014. MEDTRONIC INVESTIGATION OF 2 RETURNED SUSPECT OPEN SPINE CLAMPS FIND THAT IN EACH OF THE CLAMPS, THE ADJUSTMENT SCREW THREADS ARE WORN DOWN IN THE MIDDLE OF THE TRAVEL AND NICKED NEAR THE HEAD OF THE SCREW. THERE ARE TOOL MARKS ALL AROUND THE SCREW HEAD. THE CLAMP FACE IS BENT TO ONE SIDE. THE RETAINER RING ON THE END OF THE ADJUSTMENT SCREW IS STRETCHED FROM BEING OVER TIGHTENED AND NOW ALLOWS SOME SLIPPAGE IN THE TRAVEL OF THE CLAMP FACE. PHYSICAL DAMAGE, DIRECTLY CAUSED EVENT.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE, REGISTERED NURSE, REPORTED TWO DAMAGED OPEN SPINE CLAMPS. ON EACH OF THE SPINE CLAMPS THE SCREW BECOMES STRIPPED AND THE HEX HEAD IS STRIPPED WHILE TIGHTENING. REPLACEMENT INSTRUMENTS WERE REQUESTED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119017 OPEN SPINE CLAMP, TITANIUM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 120726 & 120301

    Patients

    Seq Age Sex Outcome Treatment
    1