BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTE-STACK SPINAL SYSTEM

    MDR report key: 1181722 · Received September 17, 2008

    Report

    Report Number
    1030489-2008-00517
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Report Date
    August 20, 2008
    Manufacturer
    SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    MQP
    PMA / PMN Number
    K052261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PEEK IMPLANT BROKE DURING IMPACTION. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTE-STACK SPINAL SYSTEM VB REPLACEMENT MQP SOFAMOR DANEK DEGGENDORF GMBH NA NM31

    Patients

    Seq Age Sex Outcome Treatment
    1