BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYAXIAL SCREW DRIVER

    MDR report key: 3492513 · Received October 25, 2013

    Report

    Report Number
    2032593-2013-00069
    Event Type
    Malfunction
    Date Received
    October 25, 2013
    Date of Event
    October 1, 2013
    Report Date
    October 25, 2013
    Manufacturer
    SEASPINE, INC.
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF THREE REPORTS CONCERNING THE SAME PT AND SAME SURGERY. THIS REPORT CONCERNS A MALIBU POLYAXIAL SCREWDRIVER. (PRODUCT ID 91-2110). IT WAS REPORTED DURING A POSTERIOR LUMBAR INTERBODY FUSION (PLIF) SURGERY, THE MALIBU POLYAXIAL SCREWDRIVER TIP SHEERED OFF IN THE SCREW. THE SCREWDRIVER TIP WAS RECOVERED AND DISCARDED. THERE WAS A 10 TO 15 MINUTE DELAY IN SURGERY DUE TO THE REPORTED ISSUES. THERE WAS NO REPORTED INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549678 POLYAXIAL SCREW DRIVER MALIBU HXX SEASPINE, INC. AL552404F

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR