BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSKELETON TT INTERBODY SYSTEM

    MDR report key: 12148761 · Received July 12, 2021

    Report

    Report Number
    3006340236-2021-00017
    Event Type
    Malfunction
    Date Received
    July 12, 2021
    Date of Event
    June 24, 2021
    Report Date
    September 29, 2021
    Manufacturer
    TITAN SPINE, LLC
    Product Code
    HWR
    UDI-DI
    00191375030201
    PMA / PMN Number
    K083714
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PART# 4200-1036; LOT# Y191207 AFTER VISUAL AND OPTICAL EXAMINATION, IT APPEARS THAT THE THREADED TIP HAS BEEN BROKEN FROM THE PIVOT PIN FROM WHAT APPEARS TO BE OVERLOAD. THIS IS CONSISTENT WITH OVERLOAD. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH STENOSIS FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TLIF INSERTER BROKE DURING INSERTION OF A TITAN TT IMPLANT. THE PART OF THE INSERTER THAT THREADS INTO THE CAGE BROKE DURING INSERTION. WE HAD TO USE A HOSPITAL INSTRUMENT TO GRAB AND UNTHREAD IT FROM THE CAGE IN ORDER TO GET IT OUT. THE SCREWDRIVER TIP BROKE DURING INSERTION OF AN ILIAC SCREW. THE BONE WAS SO HARD, THAT IT PUT A LOT OF TORQUE AND STRESS ON THE DRIVER. I DID NOT REALIZE THE DRIVER HAS SHEERED OFF UNTIL THE NEXT DAY WHEN I WAS PUTTING UP THE SET. THE TIP OF THE DRIVER REMAINS IN THE TULIP HEAD OF THE SCREW AND IS LOCKED IN PLACE BY THE ROD AND SET SCREW.  IT WAS REPORTED THAT THE FRAGMENT OF THE DRIVER WAS NOT REMOVED. IT IS INSIDE THE SCREW LOCKED IN PLACE BY THE ROD AND SET SCREW. NO ADDITIONAL INTERVENTION IS PLANNED OR WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046056 ENDOSKELETON TT INTERBODY SYSTEM DRIVER, PROSTHESIS HWR TITAN SPINE, LLC 4200-1036 Y191207 00191375030201

    Patients

    Seq Age Sex Outcome Treatment
    1