BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE

    MDR report key: 2030482 · Received March 16, 2011

    Report

    Report Number
    3007617183-2011-00001
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 15, 2011
    Manufacturer
    VERTEBRAL TECHNOLOGIES, INC.
    Product Code
    MAX
    PMA / PMN Number
    K091988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A MODULAR DEVICE CONSISTING OF AS MANY AS SIX SEGMENTS. ONLY ONE OF THE SEGMENTS WAS REMOVED FROM THE PT AND RETURNED TO VERTEBRAL TECHNOLOGIES INC. FOR EVALUATION. THE REMAINING SEGMENTS ARE STILL IN THE PT WHO IS DOING FINE.

    Description of Event or Problem · 1

    ON (B)(4) 2011, VERTEBRAL TECHNOLOGIES REC'D WORD OF A SURGICAL REVISION ON A PT HAVING DISCOMFORT/PAIN AFTER 24 DAYS POST OP. DR. (B)(6) HAD DETERMINED THROUGH CT SCAN THAT THE C SEGMENT HAD BECOME DISENGAGED FROM THE ADJACENT B SEGMENT AND THE DEVICE HAD ROTATED APPROX 45 DEGREES WITHIN THE DISC SPACE. INITIAL POST OP X-RAYS SHOWED PROPER ALIGNMENT OF THE SEGMENTS. PEDICLE RODS/SCREWS WERE NOT USED FOR THE INITIAL FUSION ATTEMPTS. A SPINOUS PROCESS PLATE WAS USED FOR SUPPLEMENTAL FIXATION. DR. (B)(6) REMOVED THE SPINOUS PROCESS PLATE AND C SEGMENT. DR. (B)(6) THEN INSTALLED PEDICLE ROD/SCREW FIXATION AND LEFT THE REMAINING 4 ASSEMBLED SEGMENTS IN THE DISC SPACE. POST REVISION SHOWS THE RODS AND SCREWS AND THE INTERFUSE P DEVICE MINUS THE C SEGMENT (PT STILL HAD 4 ASSEMBLED SEGMENTS 1A AND 3B'S) VTI REC'D THE C SEGMENT FOR EVALUATION ON (B)(6) 2011. AFTER CAREFUL EXAMINATION, THE DEVICE PROVED COMPROMISED, MISSING A POSTERIOR BEAD. ALL THE RADIOGRAPHS AND THE CT SCAN VERIFY THAT THE TANTALUM MARKER BEAD WAS PRESENT PRIOR TO REMOVAL/REVISION. THE C SEGMENT ALSO HAD DEFORMATION NEAR THE MARKER BEAD WHERE THE SEGMENT WAS GRASPED WITH A RONGEUR OR SIMILAR GRASPING DEVICE. WHEN THE RONGEUR/PLIERS DEFORMED THE SEGMENT, IT DISLODGED THE MARKER BEAD AND MADE IT IMPOSSIBLE TO EVALUATE THE ENGAGEMENT FORCE. A DECISIVE CONCLUSION WILL BE DIFFICULT TO ATTAIN WITH THE COMPROMISED SEGMENT. WE CAN DETERMINE THAT THERE MAY NOT HAVE BEEN PROPER LOADING OF THE IMPLANT DUE TO THE ORIENTATION OF THE DEVICE IN THE DISC SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE INTERVERTEBRAL BODY FUSION DEVICE MAX VERTEBRAL TECHNOLOGIES, INC. 9076-12-20-5 100623-02

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R