BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T2 ALTITUDE¿ EXPANDABLE CORPECTOMY SYSTEM

    MDR report key: 3870937 · Received June 12, 2014

    Report

    Report Number
    1030489-2014-02744
    Event Type
    Injury
    Date Received
    June 12, 2014
    Report Date
    August 15, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    MQP
    PMA / PMN Number
    K100976
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT VISUAL AND OPTICAL INSPECTION OF RETAINING FEATURES IDENTIFIED ASYMMETRICAL WITNESS MARKS NOTED AT RETAINING FEATURE. MANUAL FUNCTIONAL EVALUATION OF IMPLANT FOUND IMPLANT ABLE TO BE PROPERLY EXTENDED, AND THE LOCKING FUNCTION AUTOMATICALLY ENGAGING. EVALUATION OF IMPLANT WITH 200LBF COMPRESSIVE LOAD CELL AT HIGHEST AND LOWEST SETTING FOUND IMPLANT DID NOT RELEASE OR COLLAPSE. UNABLE TO REPLICATE CUSTOMER CONCERN; AFTER VISUAL, OPTICAL AND FUNCTIONAL EVALUATION, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE IMPLANT OR ASSOCIATED COMPONENTS. THE IMPLANT APPEARS TO BE CAPABLE OF PERFORMING ITS INTENDED FUNCTION.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4) THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE. IT WAS REPORTED AT AN UNKNOWN TIME THAT THE "IMPLANT IS COLLAPSED." NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347487 T2 ALTITUDE¿ EXPANDABLE CORPECTOMY SYSTEM SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP MEDTRONIC SOFAMOR DANEK USA, INC UM12D280

    Patients

    Seq Age Sex Outcome Treatment
    1