BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTE-STACK SPINAL SYSTEM

    MDR report key: 1547284 · Received November 20, 2009

    Report

    Report Number
    1030489-2009-01100
    Event Type
    Malfunction
    Date Received
    November 20, 2009
    Date of Event
    October 30, 2009
    Report Date
    October 30, 2009
    Manufacturer
    SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    ODP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 2960822, 510K # K041556 WAS CLEARED IN THE UNITED STATES. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL PRODUCT INFO. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERBODY CAGE WAS INITIALLY PLACED TOO FAR ANTERIORLY. DURING ATTEMPTS TO REPOSITION THE CAGE, THE THREADS WERE "PULLED OUT". THE FINAL POSITION OF THE INTERBODY CAGE WAS ACCEPTABLE, BUT NOT OPTIMAL. THERE WERE NO REPORTED PT COMPLICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK