BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSKELETON¿ TO INTERBODY SYSTEM

    MDR report key: 14672826 · Received June 13, 2022

    Report

    Report Number
    3006340236-2022-00010
    Event Type
    Injury
    Date Received
    June 13, 2022
    Date of Event
    May 20, 2022
    Report Date
    June 13, 2022
    Manufacturer
    TITAN SPINE, INC.
    Product Code
    MAX
    PMA / PMN Number
    K102067
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 RECEIVED FROM HEALTH CARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH LUMBAR STENOSIS, L4-5 GRADE 1 SPONDYLOLISTHESIS WITH INSTABILITY, SYNOVIAL CYST FOR SPINAL PLIF THERAPY AT L3-5. IT WAS REPORTED THAT THE CAGE WAS MIGRATED POSTERIORLY. THE PATIENT HAD BACK PAIN AS SYMPTOMS. DURAL TEAR DURING REMOVAL OF THE CAGE. REPAIRED BY THE SURGEON. A REVISION SURGERY WAS DONE TO REMOVE THE CAGE FROM L3-4, PLACED ADDITIONAL SCREWS AT L2 AND EXTENDED TO THAT LEVEL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1426640 ENDOSKELETON¿ TO INTERBODY SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX TITAN SPINE, INC. 3114-2609 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention