BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LDR SPINE ROI-A INTERBODY FUSION DEVICE

    MDR report key: 1732327 · Received June 9, 2010

    Report

    Report Number
    3004788213-2010-00002
    Event Type
    Injury
    Date Received
    June 9, 2010
    Date of Event
    May 11, 2010
    Report Date
    June 9, 2010
    Manufacturer
    LDR MEDICAL
    Product Code
    MAX
    PMA / PMN Number
    K082262
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL ON-GOING. ADDITIONAL CATALOG #: IR2008T. ADDITIONAL LOT #: 223105/4. ADDITIONAL EXPIRATION DATE: 06/01/2014. ADDITIONAL MANUFACTURE DATE: 06/2009.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A REVISION SURGERY OF AN ROI-A INTERBODY FUSION CONSTRUCT. A SACRAL FRACTURE AT L5/S1 WAS OBSERVED DURING REVISION SURGERY. PRELIMINARY INVESTIGATION INDICATES THAT ROI-A CONSTRUCT MAY NOT HAVE BEEN IMPLANTED CORRECTLY DURING THE INITIAL 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 76011300

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention