BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERISMA-LP NAVIGATED INSTRUMENTS

    MDR report key: 12207186 · Received July 21, 2021

    Report

    Report Number
    3009962553-2021-00003
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    June 28, 2021
    Report Date
    July 16, 2021
    Manufacturer
    CLARIANCE SAS
    Product Code
    OLO
    UDI-DI
    03700780638222
    PMA / PMN Number
    K202956
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON HAD TO USE A DIFFERENT SYSTEM DELAYING THE SURGERY BY 30 MINUTES.

    Description of Event or Problem · 1

    BOTH SCREWDRIVERS AVAILABLE IN ERISMA-LP NAVIGATED INSTRUMENTS WOULD NOT DISENGAGE FROM THE SCREW WHILE BEING IMPLANTED. IT WAS DISASSEMBLED AND REASSEMBLED BY "STERILE PROCESSING DEPARTMENT" INCORRECTLY, CAUSING THE LOCKING MECHANISM TO FUNCTION ABNORMALLY. THE SURGEON HAD TO USE A DIFFERENT SYSTEM DELAYING THE SURGERY BY 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104578 ERISMA-LP NAVIGATED INSTRUMENTS ERISMA-LP NAVIGATED DRIVER OLO CLARIANCE SAS 48710003 M3K4X/1 03700780638222

    Patients

    Seq Age Sex Outcome Treatment
    1