BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERISMA LP

    MDR report key: 9786165 · Received March 4, 2020

    Report

    Report Number
    3009962553-2019-00005
    Event Type
    Malfunction
    Date Received
    March 4, 2020
    Date of Event
    August 20, 2019
    Report Date
    September 19, 2019
    Manufacturer
    CLARIANCE SAS
    Product Code
    HXX
    UDI-DI
    03700780625154
    PMA / PMN Number
    K153326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP REPORT WILL BE FILED ONCE THE ANALYSIS IS PERFORMED. 12/20/2019 - AFTER ANALYSIS USING A MAGNIFYING GLASS, IT APPEARS A NET BREAK OF THE TIP OF THE SHAFT. MOREOVER, IT IS POSSIBLE TO NOTICE A STOP AT THE OPPOSITE OF THE BREAK POINT. ALL STRIATIONS ARE IN THE SAME DIRECTION. THIS BREAK IS CHARACTERISTIC OF OVER-BENDING BY THE SURGEON. - ATTACHMENT: [30RA23.PDF].

    Description of Event or Problem · 0

    THE SURGEON EXPERIENCED TWO BROKEN TIPS ON THE PEDICLE SCREW DRIVERS. ONE OF THE TIPS WAS BROKEN OFF IN THE SCREW AND DISPOSED OF WITH THE SCREW. THE TIP WAS RETRIEVED AND NOT LEFT IN THE PATIENT. THE SECOND DRIVER TIP WAS CRACKED, BUT NOT BROKEN OFF COMPLETELY. THE BROKEN DRIVER OCCURRED AT L5-S1 AND BOTH BREAKAGES WERE AT THE SAME PILOT HOLE. NO HARM OCCURRED TO THE PATIENT AND THE SURGERY COMPLETED WITHOUT FURTHER INCIDENT.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE FILED ONCE THE ANALYSIS IS PERFORMED.

    Description of Event or Problem · 1

    THE SURGEON EXPERIENCED TWO BROKEN TIPS ON THE PEDICLE SCREW DRIVERS. ONE OF THE TIPS WAS BROKEN OFF IN THE SCREW AND DISPOSED OF WITH THE SCREW. THE TIP WAS RETRIEVED AND NOT LEFT IN THE PATIENT. THE SECOND DRIVER TIP WAS CRACKED, BUT NOT BROKEN OFF COMPLETELY. THE BROKEN DRIVER OCCURRED AT L5-S1 AND BOTH BREAKAGES WERE AT THE SAME PILOT HOLE. NO HARM OCCURRED TO THE PATIENT AND THE SURGERY COMPLETED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248775 ERISMA LP SCREWDRIVER SHAFT HXX CLARIANCE SAS 18911039 H224X 03700780625154

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR