BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTE-STACK SPINAL SYSTEM

    MDR report key: 1800047 · Received August 11, 2010

    Report

    Report Number
    1030489-2010-01045
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 15, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MQP
    PMA / PMN Number
    K052261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE REMAINS IMPLANTED. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PEEK DEVICE BROKE ON SECONDARY IMPACTION. THE BROKEN DEVICE WAS IMPLANTED IN THE PT BECAUSE IT WAS BELIEVED THAT THE DEVICE WOULD NOT MIGRATE OR CAUSE ANY INJURY TO THE PT. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTE-STACK SPINAL SYSTEM VB REPLACEMENT MQP MEDTRONIC SOFAMOR DANEK NA H09L8417

    Patients

    Seq Age Sex Outcome Treatment
    1