BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 4294948 · Received December 3, 2014

    Report

    Report Number
    1030489-2014-04631
    Event Type
    Malfunction
    Date Received
    December 3, 2014
    Date of Event
    November 3, 2014
    Report Date
    November 3, 2014
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    K094025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 # 9393008, 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 # 9393008, 510K # K094025 WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A "SPONDYLOLYSTHESIS L3-L5 TO POSTERIOR OPEN PROCEDURE AT LEVELS L3-L4." DURING SURGERY THE CAGE BROKE DURING THE IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779915 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG TE33

    Patients

    Seq Age Sex Outcome Treatment
    1