BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTE-STACK SPINAL SYSTEM

    MDR report key: 1002365 · Received February 20, 2008

    Report

    Report Number
    1030489-2008-00082
    Event Type
    Injury
    Date Received
    February 20, 2008
    Report Date
    January 24, 2008
    Manufacturer
    SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    MQP
    PMA / PMN Number
    K041556
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS DISCARDED. PRODUCT RETURN IS NOT POSSIBLE. UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL PROCEDURE USING INTERBODY DEVICE AT L4-L5. THE DEVICE MIGRATED POSTERIORLY INTO THE FORAMEN A WEEK POST OP. THE REVISION SURGERY WAS PERFORMED TO REPLACE THE IMPLANT WITH A LARGER SIZED IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTE-STACK SPINAL SYSTEM VB REPLACEMENT MQP SOFAMOR DANEK DEGGENDORF GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention