BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    MDR report key: 2940391 · Received February 3, 2013

    Report

    Report Number
    1030489-2013-00353
    Event Type
    Malfunction
    Date Received
    February 3, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    MQP
    PMA / PMN Number
    K052261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP OF THE INSERTER BROKE OFF. NO PATIENT COMPLICATIONS WERE REPORTED. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45711 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP MEDTRONIC SOFAMOR DANEK USA, INC SA09F106

    Patients

    Seq Age Sex Outcome Treatment
    1