BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LDR SPINE ROI-C INTERBODY FUSION DEVICE

    MDR report key: 2111020 · Received May 5, 2011

    Report

    Report Number
    3004788213-2011-00001
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    March 24, 2011
    Report Date
    May 5, 2011
    Manufacturer
    LDR MEDICAL
    Product Code
    ODP
    PMA / PMN Number
    K091088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY PRELIMINARY INFORMATION HAS BEEN RECEIVED AND IS STILL UNDER INTERNAL REVIEW. INVESTIGATION INTO THIS EVENT IS ON-GOING. ADDITIONAL CATALOG #: MC1332P; ADDITIONAL LOT # 829714000; ADDITIONAL EXPIRATION DATE: 07/01/2014. ADDITIONAL DEVICE MANUFACTURE DATE: 07/2009.

    Description of Event or Problem · 1

    SURGEON REPORTED ON (B)(6) 2011 THAT A PT UNDERWENT A REVISION OF AN ROI-C VERTEBRIDGE INTERBODY FUSION CONSTRUCT AT C6-C7. PRELIMINARY INVESTIGATION TO DATE INDICATES THAT THE ORIGINAL SURGERY WAS COMPLETED (B)(6) 2010, AND WAS UNEVENTFUL WITHOUT ANY COMPLICATIONS. THE SURGEON FOLLOWED THE SURGICAL TECHNIQUE, HOWEVER, A LARGE ANCHORING PLATE WAS USED WITH A H6MM CAGE CONTRARY TO THE DOCUMENTED SURGICAL TECHNIQUE FOR ROI-C. POST ORIGINAL SURGERY PT WAS ACTIVE AND DOING WELL UNTIL (B)(6) 2010 WHEN PT MADE AN APPOINTMENT WITH A CHIEF COMPLAINT OF SIGNIFICANT CERVICALGIA. MEDICATION INTAKE INCREASED AND PLAIN RADIOGRAPHS SHOWED A SUPERIOR ANCHORING PLATE FRACTURE WITHIN THE BODY OF C6. PT HAD POSTERIOR DECOMPRESSION WITH INSTRUMENTATION AND FUSION SURGERY ON (B)(6) 2011. THE ROI-C CONSTRUCT WAS NOT REMOVED DURING THE REVISION. POST-REVISION, PT IS DOING WELL, ABLE TO DO LIGHT ACTIVITY, HAS DECREASED MEDICATION AND ARM PAIN IS RESOLVED. INVESTIGATION INTO THIS EVENT IS ON-GOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LDR SPINE ROI-C INTERBODY FUSION DEVICE INTERBODY FUSION DEVICE ODP LDR MEDICAL NA 224959/8

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention