BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LDR SPINE ROI-C SYSTEM

    MDR report key: 5442736 · Received February 17, 2016

    Report

    Report Number
    3004903783-2016-00004
    Event Type
    Injury
    Date Received
    February 17, 2016
    Date of Event
    January 13, 2016
    Report Date
    February 17, 2016
    Manufacturer
    LDR MEDICAL
    Product Code
    MQP
    PMA / PMN Number
    K080728
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2014039 - LDR SPINE USA, INC. (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF LDR MEDICAL (MANUFACTURER). THE REPORT INDICATES THE PATIENT WAS TREATED AT 4 LEVELS, C3-C7 FOR CERVICAL STENOSIS AND MYELOPATHY WITH PEEK CAGES FOR FUSION. THE PATIENT HAD SYMPTOMS OF LEFT ARM AND NECK PAIN AND DELTOID WEAKNESS. LARGE OSTEOPHYTES AND SEVERE STENOSIS WERE REPORTED AND X-RAYS SHOWED COLLAPSED DISC SPACES. ONE WEEK FOLLOWING THE FUSION SURGERY, THE PATIENT CONTINUED TO HAVE NECK AND ARM PAIN AND DELTOID WEAKNESS. THE SURGEON DECIDED TO REMOVE THE TWO MIDDLE PEEK CAGES (SAME LOT#S) AT LEVELS C4/5 AND C5/6 TO ENSURE THE DISCECTOMIES WERE COMPLETE AND THOROUGH, AND PLACED NEW PEEK CAGES OF THE SAME SIZE INTO THE DISC SPACES. REVIEW OF THE INITIAL AND REVISION POST OP X-RAYS SHOW WELL-PLACED CAGES AND ANCHOR PLATES. THE PATIENT STILL REPORTED NECK AND ARM PAIN, AND DELTOID WEAKNESS. THE SURGEON IS CONTINUING PATIENT FOLLOW UP. THERE IS NO EVIDENCE TO INDICATE A DEVICE ISSUE. DISPOSED BY HOSPITAL.

    Description of Event or Problem · 0

    REVISION SURGERY 1 WEEK POST INITIAL IMPLANTATION TO REMOVE AND REPLACE THE MIDDLE 2 PEEK CAGE DEVICES OF A 4 LEVEL FUSION FROM C3-C7 DUE TO PATIENT CONTINUED PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98121 LDR SPINE ROI-C SYSTEM SPINAL PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE MQP LDR MEDICAL MC1452P 43686

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention