BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTE-STACK SPINAL SYSTEM

    MDR report key: 2060103 · Received April 15, 2011

    Report

    Report Number
    1030489-2011-00430
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 21, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    MQP
    PMA / PMN Number
    K052261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUALLY CONFIRMED ANTERIOR "NOSE" PORTION OF IMPLANT IS CRACKED. THE CRACKS APPEAR TO HAVE INITIATED LOCATED AT THE BASE OF THE DIAMOND SHAPED FACETS, WHICH COULD ACT AS A STRESS CONCENTRATOR. ADDITIONALLY, A SMALL ANTERIOR PORTION OF THE IMPLANT HAS BEEN BROKEN OFF, AND NOT RETURNED FOR ANALYSIS. THE LOCATION AND NATURE OF THE FRACTURE SUGGESTS INSUFFICIENT INTERVERTEBRAL SPACE PREPARATION. 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 BROKE UPON INSERTION AT THE TIP WHERE THE IMPLANT MEETS THE INSERTER. ALTHOUGH THE IMPLANT WAS USED IN SURGERY, NO PATIENT 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 PUERTO RICO OPERATIONS NA H10F0738

    Patients

    Seq Age Sex Outcome Treatment
    1