BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 10702911 · Received October 20, 2020

    Report

    Report Number
    1030489-2020-01445
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    October 1, 2020
    Report Date
    October 20, 2020
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG #: 9393007, 510K #: K172199, UDI # :(B)(4) WAS CLEARED IN THE UNITED STATES. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE R EPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPONDYLOLISTHESIS FOR TLIF PROCEDURE WITH VOYAGER 5.5 AND MAZOR X. IT WAS REPORTED THAT THE CAGE WAS BROKEN AND WAS THROWN INTO THE TRASH BY THE CUSTOMER. CAGE WAS PROPERLY CLAMPED IN THE INSERTER AND BROKE DURING IMPLANTATION. THE DEVICE WAS REPLACED AND THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WERE NO PATIENT SYMPTOMS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171348 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG 9393007INT 88JX

    Patients

    Seq Age Sex Outcome Treatment
    1