BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERBODY FUSION DEVICE

    MDR report key: 4171532 · Received October 14, 2014

    Report

    Report Number
    1030489-2014-04020
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    October 7, 2014
    Report Date
    March 25, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    MAX
    PMA / PMN Number
    K094025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 9393007, PRODUCT CODE MAX WAS CLEARED IN THE UNITED STATES. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 9393007, 510K # K094025 WAS CLEARED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ANALYSIS OF THE RETURNED DEVICE SHOWS THAT ONLY PART OF THE SPACER WAS RETURNED SIX FRAGMENTS OF THE SPACER 4 PIECES ¿3MM X 3MM AND 2 PIECES ¿8MM X 8MM. MICROSCOPIC ANALYSIS REVEALS THAT THERE ARE SOME INDICATIONS OF OVERLOAD ON SOME OF THE FRACTURE SURFACES. HOWEVER DUE TO THE CONDITIONS AND SIZE OF THE PORTION RETURNED NO ROOT CAUSE FOR THE FAILURE COULD BE DETERMINED. BECAUSE OF THE CONDITION OF THE RETURN NO ROOT CAUSE COULD BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE AT L5-S1. DURING IMPLANTATION, THE CAGE BROKE AND BROKEN PIECES OF THE CAGE REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650201 INTERBODY FUSION DEVICE INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH YU81

    Patients

    Seq Age Sex Outcome Treatment
    1