BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERISMA LP

    MDR report key: 9157930 · Received October 4, 2019

    Report

    Report Number
    3009962553-2019-00003
    Event Type
    Malfunction
    Date Received
    October 4, 2019
    Date of Event
    July 17, 2017
    Report Date
    September 19, 2019
    Manufacturer
    CLARIANCE SAS
    Product Code
    HXX
    UDI-DI
    03700780625178
    PMA / PMN Number
    K153326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE BREAKAGE OF THE QUICK-CONNECT ROD WAS CAUSED BY AN INCORRECT ASSEMBLY OF THE SCREWDRIVER BEFORE USE. WHEN THE SCREWDRIVER SHAFT IS NOT PROPERLY ENGAGED IN THE QUICK-CONNECT ROD, THIS CAUSES THE BREAKAGE OF THE STRIPS BY INTERFERING WITH THE WINDOW OF THE SCREWDRIVER TUBE.

    Description of Event or Problem · 1

    THE SURGEON INITIALLY IMPLANTED A 7.5MM DIAMETER POLYAXIAL SCREW AND WAS UNABLE TO RELEASE THE LOCKING MECHANISM OF THE SCREWDRIVER. AS A CONSEQUENCE, THE SURGEON REMOVED THE POLYAXIAL SCREW INITIALLY IMPLANTED. HE USED ANOTHER SCREWDRIVER READILY AVAILABLE IN THE SET AND REPLACED THE 7.5MM DIAMETER POLYAXIAL SCREW WITH A 8.5MM DIAMETER POLYAXIAL SCREW. NO PATIENT HARM WAS REPORTED AND THE SURGERY WAS COMPLETED WITH NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952387 ERISMA LP TUBE HXX CLARIANCE SAS 18912026 G903N 03700780625178

    Patients

    Seq Age Sex Outcome Treatment
    1