BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERPOS PLS

    MDR report key: 2093276 · Received April 14, 2011

    Report

    Report Number
    2032499-2011-00092
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 31, 2011
    Manufacturer
    INTERVENTIONAL SPINE, INC.
    Product Code
    HXX
    PMA / PMN Number
    K082795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON USED I-SPINE CONTRALATERAL TO A PEDICLE SCREW CONSTRUCT AT L4-S1 TO SUPPLEMENT 2ND SCREW THAT THEY USED. REMOVED THE SCREWDRIVER, PULL PIN WAS STUCK TO END OF DRIVER. TRIED TO SCREW PULL PIN BACK IN. THINKS HE GOT IT ENGAGED, NOTED THAT IT COMPRESSED A LITTLE BIT. WHEN HE TOOK COMPRESSION TOOL OUT, THE PULL PIN WAS IN THE COMPRESSION TOOL. USED DRIVER TO MAKE SURE IT WAS FULLY SEATED. PT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERPOS PLS HXX INTERVENTIONAL SPINE, INC. 9045-02 083010-B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention