BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INION S-1 BIODEGR. GRAFT CONTAINMENT PLATE

    MDR report key: 2236980 · Received August 31, 2011

    Report

    Report Number
    9710629-2011-00009
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    June 22, 2011
    Report Date
    August 31, 2011
    Manufacturer
    INION OY
    Product Code
    OJB
    PMA / PMN Number
    K071810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PART 6: EVAL AND CONCLUSION WILL BE PROVIDED IN A F/U REPORT AFTER COMPLETION.

    Description of Event or Problem · 1

    PT HAD A C5-C7 INION PLATE FOR AN ACDF IN (B)(6) 2011. THE PT DEVELOPED LOSS OF HER LORDOTIC CURVATURE AFTER THE SURGERY ON F/U FILMS: REVERSAL OF LORDOSIS AT C5-7. PARTIAL COLLAPSE OF C4/5 ALSO. IN THE REVISION SURGERY THE INION PLATE AND SCREWS WERE REMOVED. THE SCREW HEADS WERE FOUND LOOSE WHICH ACCORDING TO SURGEON MAY OR MAY NOT HAVE OCCURRED DURING DISSECTING FIBROUS TISSUE OFF THE PLATE. THE PLATE CRACKED INTO TWO DURING REMOVAL. THE PT THEN WAS RECONSTRUCTED WITH A NEW C4/5 ACDF AND REVISION OF THE C5/6 FUSION AND PLACEMENT OF A NEW CAGE IN THE C5/6 SPACE IN ADDITION TO THE CAGE THAT WAS ALREADY THERE. THEN A METAL PLATE WAS USED FROM C4-7 TO COMPLETE THE PROCEDURE. SURGEON CONCLUSION IS LOSS OF BONE STRUCTURE. THE PT HAD BEEN IN MOTOR VEHICLE ACCIDENT PRIOR TO THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INION S-1 BIODEGR. GRAFT CONTAINMENT PLATE GRAFT CONTAINMENT PLATE OJB INION OY SPN-5017 0804052

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention INION S-1 SCREWS FOR PLATE FIXATION.