BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTE-STACK SPINAL SYSTEM

    MDR report key: 1062931 · Received June 19, 2008

    Report

    Report Number
    1030489-2008-00280
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 29, 2008
    Report Date
    May 28, 2008
    Manufacturer
    SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    MQP
    PMA / PMN Number
    K041197
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO THE MFR FOR EVAL. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A FOUR-LEVEL CORPECTOMY USING VERTEBRAL BODY REPLACEMENT DEVICES WITH ANTERIOR AND POSTERIOR FIXATION AT C3/6. THE SUPERIOR END CAP REPORTEDLY BECAME DISLODGED FROM THE CONSTRUCT DURING IMPACTION. THE SURGEON RE-ASSEMBLED THE CONSTRUCT AND IMPLANTED IT. POST-OPERATIVE IMAGES REPORTEDLY DEMONSTRATE THAT THE END CAP HAS DISENGAGED FROM THE CENTER STRUT. A REVISION SURGERY WAS PERFORMED FIVE DAYS POST-OP TO REPLACE THE CONSTRUCT. THE PT REPORTEDLY IS DOING WELL AFTER THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTE-STACK SPINAL SYSTEM VB REPLACEMENT MQP SOFAMOR DANEK DEGGENDORF GMBH NA MT18

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention