BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSKELETON TT INTERBODY SYSTEM

    MDR report key: 11138052 · Received January 8, 2021

    Report

    Report Number
    3006340236-2021-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Date of Event
    December 29, 2020
    Report Date
    May 14, 2021
    Manufacturer
    TITAN MANUFACTURING MEQUON
    Product Code
    HWR
    UDI-DI
    00191375030201
    PMA / PMN Number
    K083714
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3:PART #4200-1036 LOT# Y190104 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. H6: METHOD CODE AND RESULT CODE ARE UPDATED. 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.

    Description of Event or Problem · 0

    THE INFORMATION WAS RECEIVED FROM A HEALTH CARE FACILITY VIA A MANUFACTURING REPRESENTATIVE FOR PATIENT REGARDING TLIF INTERBODY FUSION OF THE LUMBER SPINE FOR IMPLANTING A TITAN TT SPACER AT L4-L5 SPINAL THERAPY. IT WAS REPORTED THAT WHILE IMPACTING THE TITAN TT INTERBODY CAGE INTO THE DISC SPACE, THE INSERTER ATTACHED TO THE CAGE RELEASED AND WAS NO LONGER POSITIVELY CONNECTED TO THE CAGE. THE INTERNAL MECHANISM IN THE INSERTER THAT THREADS INTO THE CAGE BROKE OFF AND FELL APART IN THE PATIENT. THE THREADED PORTION HAD TO BE REMOVED WITH A NEEDLE DRIVER AS IT WAS STILL THREADED IN TO THE CAGE AND THE SPRING WAS LOOSE IN THE DISC SPACE. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WAS NO FURTHER COMPLICATION REPORTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE INFORMATION WAS RECEIVED FROM A HEALTH CARE FACILITY VIA A MANUFACTURING REPRESENTATIVE FOR PATIENT REGARDING TLIF INTERBODY FUSION OF THE LUMBER SPINE FOR IMPLANTING A TITAN TT SPACER AT L4-L5 SPINAL THERAPY. IT WAS REPORTED THAT WHILE IMPACTING THE TITAN TT INTERBODY CAGE INTO THE DISC SPACE, THE INSERTER ATTACHED TO THE CAGE RELEASED AND WAS NO LONGER POSITIVELY CONNECTED TO THE CAGE. THE INTERNAL MECHANISM IN THE INSERTER THAT THREADS INTO THE CAGE BROKE OFF AND FELL APART IN THE PATIENT. THE THREADED PORTION HAD TO BE REMOVED WITH A NEEDLE DRIVER AS IT WAS STILL THREADED IN TO THE CAGE AND THE SPRING WAS LOOSE IN THE DISC SPACE. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WAS NO FURTHER COMPLICATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38751 ENDOSKELETON TT INTERBODY SYSTEM DRIVER, PROSTHESIS HWR TITAN MANUFACTURING MEQUON 4200-1036 Y190104 00191375030201

    Patients

    Seq Age Sex Outcome Treatment
    1