BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERPOS PLS

    MDR report key: 2040375 · Received February 15, 2011

    Report

    Report Number
    2032499-2011-00022
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Report Date
    May 5, 2009
    Manufacturer
    INTERVENTIONAL SPINE, INC.
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: BURRS LEFT INSIDE DISTAL TIP AFTER MACHINING. FUNCTIONAL FIT CHECKED WITH 0.62" DIAMETER WIRE INSTEAD OF .099" DIAMETER ROD. CORRECTIVE ACTION: SUPPLIER MODIFIED MACHINING STEPS TO ELIMINATE BURRS. SUPPLIER IMPLEMENTED NEW FUNCTIONAL FIT TEST. IMPLEMENTED SAME FUNCTIONAL FIT TEST UPON RECEIPT FROM SUPPLIER. INITIALLY IT WAS DETERMINED THE EVENT WAS NOT REPORTABLE. ON A SUBSEQUENT RE-REVIEW, IT WAS DETERMINED THIS EVENT SHOULD HAVE BEEN REPORTED. DEVICE EVALUATION: RETURNED INSTRUMENT WAS VISUALLY INSPECTED. DISTAL TIP WAS CROSS SECTIONED AND DIMENSIONALLY MEASURED. ALL DIMENSIONS WERE WITHIN SPECIFICATION. A BURR AT THE LEADING ENTRANCE WAS NOTED, WHICH EFFECTIVELY DECREASED THE INNER DIAMETER OF THE TIP, PREVENTING THE .099" DIAMETER PORTION OF THE IMPLANT TO PASS, EFFECTIVELY PREVENTING THE IMPLANT FROM BEING SEATED ALL THE WAY INTO THE INSTRUMENT.

    Description of Event or Problem · 1

    A SURGICAL TECHNICIAN WAS TRYING TO ATTACH THE SCREW WITH THE SCREWDRIVER. THE END OF THE HEX OF THE DRIVER WOULD NOT ENTER THE HEX OF THE SCREW. THERE WERE NO PT COMPLICATIONS AS THE PROBLEM WAS FOUND BEFORE THE SCREW HAD TO BE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERPOS PLS HXX INTERVENTIONAL SPINE, INC. 9045-01 061807-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention