BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERFUSE INTERVERTEBRAL BODY FUSION SYSTEM

    MDR report key: 2651234 · Received April 9, 2009

    Report

    Report Number
    3007617183-2009-00001
    Event Type
    Injury
    Date Received
    April 9, 2009
    Date of Event
    March 1, 2009
    Report Date
    March 18, 2009
    Manufacturer
    VERTEBRAL TECHNOLOGIES INC.
    Product Code
    MAX
    PMA / PMN Number
    K080673
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A MODULAR DEVICE. FOUR MODULES WERE INITIALLY IMPLANTED INTO THE PT. THE TWO MODULES THAT WERE EXPELLED FROM THE DISC SPACE WERE REMOVED BY THE PHYSICIAN AND RETURNED TO VERTEBRAL TECHNOLOGIES, INC FOR EVAL. TWO MODULES WHICH ARE PROPERLY ALIGNED IN THE DISC SPACE REMAIN IN THE PT. INVESTIGATION RESULTS: THE DISPLACED B AND C MODULES (ONE EACH) WERE VISUALLY, DIMENSIONALLY AND FUNCTIONALLY EVALUATED. (THE VISUAL EVAL CONSISTED OF CHECKING THE TWO SEGMENTS FOR ANY SIGNS OF DAMAGE AS WELL AS PRESENCE OF THE TANTALUM MARKER BEADS. THE DIMENSIONAL EVAL CONSISTED OF CHECKING TWO SEGMENTS FOR THEIR MAJOR OUTSIDE MACHINED DIMENSIONS. THE FUNCTIONAL EVAL CONSISTED OF CHECKING THE TWO SEGMENTS FOR PROPER THREAD FIT IN THE TAPPED THROUGH HOLES AS WELL AS THE INTERFACING FIT BETWEEN THE TWO MODULES). THE MODULES MET SPEC REQUIREMENTS WITH THE EXCEPTION OF SOME MINOR GOUGES/SCRATCHES ON THE SURFACES OF THE MODULES. THESE ARE LIKELY DUE TO THE USE OF A FORCEPS DURING REMOVAL OF THE TWO MODULES FROM THE PT. NOTE: TWO MODULES WHICH ARE PROPERLY ALIGNED IN THE DISC SPACE REMAIN IN THE PT. THE MFR DOCUMENTATION WAS REVIEWED. THERE WERE NO INDICATIONS OF ANY MFR ISSUES. ALL UNITS WERE TESTED 100% FOR PROPER FIT BETWEEN THE MODULES PRIOR TO PACKAGING. INFO RECEIVED FROM THE PHYSICIAN WAS REVIEWED. THE PHYSICIAN INDICATED THAT PARTIAL ENDPLATE REMOVAL CONTRIBUTED TO DISPLACEMENT OF THE TWO MODULES. CONCLUSION: THE LIKELY CAUSE FOR THIS EVENT IS DUE TO EXCESSIVE REMOVAL OF SUBCHONDRAL BONE AT THE END PLATES. THIS RESULTED IN A LACK OF INTERFERENCE/LOAD BETWEEN THE TWO END PLATES AND THE TWO MODULES. THE LACK OF INTERFERENCE/LOAD ALLOWED THE MODULES TO MIGRATE OUTSIDE OF THE VERTEBRAL END PLATE POCKET.

    Description of Event or Problem · 1

    TEN DAYS POST-OP THE PT WAS FEELING PAIN IN THEIR LEG. EXAMINATION BY THE PHYSICIAN REVEALED THAT TWO OF THE FOUR MODULES HAD BEEN EXPELLED FROM THE DISC SPACE. THE TWO EXPELLED MODULES WERE SURGICALLY REMOVED. THE REMOVED MODULES WERE FOUND TO BE PROPERLY CONNECTED AND LOCKED TOGETHER. THE REMAINING TWO MODULES WERE INTACT IN THE DISC SPACE. THE PT HAS BEEN SEEN ON TWO SUBSEQUENT OCCASIONS AND ACCORDING TO THE PHYSICIAN THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERFUSE INTERVERTEBRAL BODY FUSION SYSTEM MAX VERTEBRAL TECHNOLOGIES INC. 9076-8-20-0 090112-01

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R