BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 6577595 · Received May 19, 2017

    Report

    Report Number
    1030489-2017-01255
    Event Type
    Malfunction
    Date Received
    May 19, 2017
    Date of Event
    April 25, 2017
    Report Date
    April 25, 2017
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 9393007, 510K# K094025 AND (B)(4) IS APPROVED FOR SALE IN US. THE PRODUCT IS NOT RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LUMBAR INTERBODY FUSION AT L4-5. INTRA-OP, UPON INSERTION OF THE INTERBODY DEVICE, THE IMPLANT BROKE AT THE PORTION ATTACHING TO THE INSERTER. SMALL OPENING INTO THE DISC SPACE CAUSED DIFFICULTY IN INTRODUCING. NO PATIENT COMPLICATIONS WERE REPORTED AND NO FRAGMENTS OF THE PRODUCT REMAINED INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359362 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG NA 51BH

    Patients

    Seq Age Sex Outcome Treatment
    1