BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERPLATE L INTERBODY FUSION DEVICE/VBR

    MDR report key: 1689187 · Received May 11, 2010

    Report

    Report Number
    3003597504-2010-00001
    Event Type
    Injury
    Date Received
    May 11, 2010
    Date of Event
    April 13, 2010
    Report Date
    May 10, 2010
    Manufacturer
    RSB SPINE
    Product Code
    MAX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    LUMBAR FUSION WAS PERFORMED ON (B) (6) 2010. PT REPORTED PAIN TWO WEEKS POST-OP. A SECOND OPERATION WAS PERFORMED ON (B) (6) 2010. THE IMPLANTS WERE IN PLACE, BUT FUSION HAD NOT YET OCCURRED. BONE QUALITY WAS OBSERVED TO BE POOR. THE INTERPLATE COMPONENTS WERE REMOVED AND REPLACED WITH INTERBODY SPACERS AND AN ANTERIOR PLATE. THE INTERPLATE COMPONENTS WERE NOT RETURNED FOR ANALYSIS, BUT WERE SAID NOT TO HAVE MALFUNCTIONED. THE INCIDENT IS BEING REPORTED BECAUSE, SURGICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERPLATE L INTERBODY FUSION DEVICE/VBR MAX, MQP MAX RSB SPINE RSB8614 FF005

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention