BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSKELETON TL ANGLE THREADED INSERTER

    MDR report key: 7288341 · Received February 22, 2018

    Report

    Report Number
    3006340236-2017-00017
    Event Type
    Malfunction
    Date Received
    February 22, 2018
    Date of Event
    October 13, 2017
    Report Date
    April 13, 2020
    Manufacturer
    TITAN SPINE, LLC
    Product Code
    LXH
    PMA / PMN Number
    K140055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: THIS REGULATORY REPORT WAS PREVIOUSLY SUBMITTED ON 22-FEB-2018 AS REGULATORY REPORT # 3006340236-2017-00017 ¿ 1 WITH "FOLLOW-UP" MARKED. PER REQUEST, IT IS BEING RESUBMITTED AS AN INITIAL REPORT. THE ROOT CAUSE OF THIS INCIDENT IS LIKELY DUE TO FATIGUE FORCE AND EXCESSIVE FORCE BEING APPLIED TO THE ASSEMBLY. THE CROSS PIN OF THE ELBOW MECHANISM PULLED THROUGH THE THIN WALL FEATURE OF THE INNER SHAFT; FATIGUE FORCE CAN PLASTICALLY DEFORM THIS THIN WALL AND EVENTUALLY RESULT IN AN ULTIMATE FAILURE OF THE MATERIAL AS WAS THE CASE IN THIS INCIDENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE ENDOSKELETON TL ANGLED TRIAL INSERTER PIN BROKE DURING EXTRACTION WHILE PERFORMING A LATERAL PROCEDURE. THE CUSTOMER WAS USING A SLAP HAMMER TO PULL THE TRIAL OUT WHILE THE INSERTER WAS STILL THREADED INTO THE TRIAL. ALL OF THE PIECES WERE ABLE TO BE RETRIEVED AS THE TRIAL WAS BEING PULLED OUT. THE SURGEON WAS ABLE TO FINISH THE TRIAL AND MOVE INTO INSERTING THE IMPLANT WITHOUT FURTHER INCIDENT. THERE ARE NO KNOWN ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134678 ENDOSKELETON TL ANGLE THREADED INSERTER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH TITAN SPINE, LLC 7200-1046 L160705

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown