BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTE-STACK® SPINAL SYSTEM

    MDR report key: 4152881 · Received October 8, 2014

    Report

    Report Number
    1030489-2014-03924
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 4, 2014
    Report Date
    December 15, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MQP
    PMA / PMN Number
    K052261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ANALYSIS OF THE RETURNED DEVICE SHOWS THAT VISUALLY CONFIRMED THAT TWO PIECES OF WHAT APPEARS TO A PEEK IMPLANT WERE RETURNED. NEITHER OF THE TWO PIECES SHOW AND MARKING TO INDEMNIFY THEM. BOTH PIECES ARE ¿1CM IN LENGTH. A REVIEW TO THE FRACTURE SURFACE INDICATES THE ITEM OVERLOADING DOING A BENDING MOMENT. THE ABOVE FINDINGS ARE CONSISTENT WITH BEND STRESS OVERLOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TLIF PROCEDURE. DURING FINAL POSITIONING, THE CAGE BROKE. THE SURGEON HAD TO REMOVE THE BROKEN PIECES OF THE CAGE BUT HAD TO LEAVE THE REST OF THE CAGE IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630426 VERTE-STACK® SPINAL SYSTEM SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP MEDTRONIC SOFAMOR DANEK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR