BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRESCENT? SPINAL SYSTEM

    MDR report key: 3907638 · Received July 1, 2014

    Report

    Report Number
    1030489-2014-02996
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    June 24, 2014
    Report Date
    August 14, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    MAX
    PMA / PMN Number
    K094025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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, AS WELL AS THE AREA OF FRACTURE INITIATION AT THE INSERTER ATTACHMENT POINT 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. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 9392507, PRODUCT CODE (B)(4) WAS CLEARED IN THE UNITED STATES. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 9392507, 510K # K094025 WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE. DURING THE PROCEDURE, WHEN THE SURGEON TRIED TO IMPACT THE CAGE INTO THE DISC SPACE, IT BROKE. WHEN THE SURGEON TRIED TO IMPACT THE SECOND CAGE, IT BROKE AS WELL. SURGEON USED NEW CAGES AND WAS ABLE TO COMPLETE THE PROCEDURE. PATIENT STATUS IS "IN GOOD HEALTH".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382089 CRESCENT? SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS XY64

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR