BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTE-STACK SPINAL SYSTEM

    MDR report key: 1994030 · Received February 16, 2011

    Report

    Report Number
    1030489-2011-00134
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    MQP
    PMA / PMN Number
    K052261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 IMPLANT FRACTURED IN THE TOP 1/3 OF THE IMPLANT. IT WAS REPORTED THAT THE IMPLANT WAS IMPLANTED TO A VERY TIGHT VERTEBRAL BODY SPACE. THE LITTLE PIECE THAT WAS BROKEN OFF FROM THE IMPLANT WAS REMOVED. IT WAS DECIDED TO LEAVE THE REST OF THE IMPLANT IMPLANTED. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTE-STACK SPINAL SYSTEM SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH NA PW75

    Patients

    Seq Age Sex Outcome Treatment
    1