BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTE-STACK® SPINAL SYSTEM

    MDR report key: 4151753 · Received October 8, 2014

    Report

    Report Number
    1030489-2014-03915
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 17, 2014
    Report Date
    November 10, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    MQP
    PMA / PMN Number
    K052261
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ANALYSIS OF THE RETURNED DEVICE SHOWS THAT MACROSCOPIC EXAMINATION CONFIRMS THE IMPLANT IS FRACTURED INTO MULTIPLE PIECES AND BROKEN. SOME OF THE BROKEN OFF PIECES ARE MISSING AND NOT RETURNED FOR ANALYSIS. THE EXTENT OF THE DAMAGE SUGGESTS SIGNIFICANT FORCE WAS UTILIZED DURING THE ATTEMPTED INSERTION. OPTICAL EXAMINATION OF THE FRACTURE SURFACES IDENTIFIED MORPHOLOGY CONSISTENT WITH BRITTLE OVERLOAD DURING INSERTION AS THE MECHANISM OF FAILURE.

    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 A PATIENT UNDERWENT A SPINAL PROCEDURE AT L5-S1. DURING SURGERY THE CAGE SHATTERED UPON INSERTION. FRAGMENTS OF THE CAGE AS WELL AS ONE METALLIC MARKER REMAINED IN THE PATIENT. SURGEON STATED THAT THE "PATIENT HAD EXCEPTIONALLY HARD BONE THAT MAY NOT HAVE BEEN CLEARED COMPLETELY AND MAY HAVE IMPEDED INSERTION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633268 VERTE-STACK® SPINAL SYSTEM SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS H13C2600

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Other