BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS IMPLANTS AND INSTRUMENTS

    MDR report key: 1832239 · Received September 13, 2010

    Report

    Report Number
    2242816-2010-00121
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 24, 2010
    Manufacturer
    EBI, LLC
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE INSERTER BROKE OFF INTO THE TULIP HEAD WHILE INSERTING THE SCREW. SCREW COULD NOT BE ENGAGED TO BACK IT OUT SO THE SURGEON BURRED AROUND THE SCREW SHAFT TO REMOVE AND REPLACE THE SCREW. PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS IMPLANTS AND INSTRUMENTS SCREW INSERTER HXX EBI, LLC PN72A

    Patients

    Seq Age Sex Outcome Treatment
    1