BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LDR SPINE ROI-A INTERBODY FUSION DEVICE

    MDR report key: 1802440 · Received August 6, 2010

    Report

    Report Number
    3004788213-2010-00003
    Event Type
    Injury
    Date Received
    August 6, 2010
    Date of Event
    July 9, 2010
    Report Date
    August 6, 2010
    Manufacturer
    LDR MEDICAL
    Product Code
    MAX
    PMA / PMN Number
    K091088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT#: 875212000, ADDITIONAL CATALOG #: MC1342P, ADDITIONAL EXPIRATION DATE: 04/01/2015. ADDITIONAL MFR DATE: 04/2010. DURING THE INITIAL ROI-C SURGERY, A CSF LEAK IN THE DURA WAS NOTED AT THE C3-C4 LEVEL, AND STEPS WERE TAKEN TO STOP THE LEAK. SIGNS OF TRAUMA AT THE C3-C4 LEVEL WERE ALSO NOTED, PRIOR TO IMPLANTATION OF THE ROI-C INTERBODY DEVICE. THIS LEAK WAS AGAIN NOTED DURING THE REVISION ROI-C PROCEDURE AND SOME DIFFICULTY WAS ENCOUNTERED IN STOPPING THE LEAK. CURRENTLY, THERE IS NO INDICATION THAT THERE IS ANY DEFICIENCY WITH QUALITY OR MANUFACTURE OF THE ROI-C DEVICE THAT MAY HAVE CONTRIBUTED TO THIS EVENT. INVESTIGATION INTO THIS EVENT IS ON-GOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A REVISION SURGERY OF AN ROI-C VERTEBRIDGE INTERBODY FUSION CONSTRUCT AT C3-C4. PRELIMINARY INVESTIGATION TO DATE INDICATES THAT DURING THE ORIGINAL SURGERY, THE SURGEON FOLLOWED THE SURGICAL TECHNIQUE, HOWEVER, THE SURGEON REPORTED HAVING DIFFICULTY IMPACTING ONE OF THE ANCHORING PLATES. THE SURGEON PLACED AN ANTERIOR CERVICAL PLATE PLACED OVER THE ROI-C CONSTRUCT AND COMPLETED SURGERY. IT HAS BEEN NOTED INTERNALLY THAT A LARGE ANCHORING WAS USED WITH AN H6MM CAGE CONTRARY TO THE DOCUMENTED SURGICAL TECHNIQUE FOR ROI-C. IMMEDIATELY POST-OP, THE PT HAD ADVERSE NEUROLOGICAL SYMPTOMS (NO MOVEMENT OF EXTREMITIES) AND THE ENTIRE ROI-C CONSTRUCT AND CERVICAL PLATE WERE REMOVED AND REPLACED WITH A SECOND C3-C4 ALLOGRAFT FUSION WITH PLATE. TO DATE, THE PT STATUS IS LIMITED MOVEMENT OF LEGS AND NO MOVEMENT OF ARMS. INVESTIGATION INTO THIS EVENT IS ON-GOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LDR SPINE ROI-A INTERBODY FUSION DEVICE INTERBODY FUSION DEVICE MAX LDR MEDICAL ROI-C CONSTRUCT 222923

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention| S