BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LDR SPINE ROI-A INTERBODY FUSION DEVICE

    MDR report key: 2163432 · Received June 29, 2011

    Report

    Report Number
    3004788213-2011-00002
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 29, 2011
    Manufacturer
    LDR MEDICAL
    Product Code
    MAX
    PMA / PMN Number
    K082262
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CATALOG #: IR2002T. ADDITIONAL LOT #: 226272/7. ADDITIONAL EXPIRATION DATE: 03/01/2015. ADDITIONAL MANUFACTURE DATE: 03/01/2010.

    Description of Event or Problem · 1

    REVISION SURGERY OF L5-S1 ROI-A WITH VERTEBRIDGE CONSTRUCT DUE TO UNRESOLVED BACK AND LEG PAIN. DEVICE WAS POSITIONED OFF-CENTER (LATERALLY). REVISION SURGERY COMPLETED USING SAME SIZE IMPLANTS WITH GOOD POSITION. PATIENT WAS REPORTED TO BE DOING FINE AFTER REVISION SURGERY.

    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-A CONSTRUCT 864018000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention