BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT ROI-C LORDOSE

    MDR report key: 9888934 · Received March 27, 2020

    Report

    Report Number
    3004903783-2017-00009
    Event Type
    Injury
    Date Received
    March 27, 2020
    Date of Event
    November 30, 2016
    Report Date
    March 30, 2020
    Manufacturer
    LDR MEDICAL
    Product Code
    OVE
    PMA / PMN Number
    K150765
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ADDITIONALLY PROVIDED INFORMATION DOES NOT IMPACT THE PREVIOUSLY REPORTED METHOD, RESULT, OR CONCLUSION CODES AS THE DEVICE EVALUATION HAS NOT ALTERED.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2014039 - LDR SPINE USA, INC. (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF LDR MEDICAL (MANUFACTURER). (B)(4). OTHER: DISTRIBUTOR (B)(4). FOLLOW-UP WITH CDRH DT SUPPORT TEAM ON (B)(6) 2020 DETERMINED THIS SUBMISSION COULD NOT BE LOCATED, SO IT IS BEING RESUBMITTED. THE CORRESPONDANCE IS ATTACH IN AN EMAIL TO THIS REPORT.

    Description of Event or Problem · 0

    AT FINAL FLOURO, MARKER APPEARED TOO POSTERIOR. SURGEON REMOVED CAGE AND PLATES AND COMPLETED CASE WITH A COMPETITOR'S CONSTRUCT. PATIENT WOKE WITH PARAPLEGIA. NEW INFORMATION WAS RECEIVED REPORTING THAT THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) POST-OP WHERE HE WAS GIVEN STEROIDS FOR EIGHT DAYS. THE PATIENT WAS DIAGNOSED WITH INCOMPLETE QUADRAPLEGIA WITH LOWER EXTREMITY WEAKNESS AND LOSS OF LOWER EXTREMITY MOTOR AND SENSORY FUNCTIONS. IT WAS ALSO REPORTED THE PATIENT HAS POST-OP RIGHT HAND AND SHOULDER, LEFT SHOULDER, LEFT HIP AND LOW BACK PAIN THAT REQUIRES MEDICATION.

    Description of Event or Problem · 0

    AT FINAL FLUORO, MARKER APPEARED TOO POSTERIOR. SURGEON REMOVED CAGE AND PLATES AND COMPLETED CASE WITH A COMPETITOR CONSTRUCT. PATIENT WOKE WITH PARAPLEGIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351170 IMPLANT ROI-C LORDOSE LDR SPINE ROI-C CERVICAL CAGE SYSTEM OVE LDR MEDICAL NA 45841

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| S