BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 9269979 · Received November 2, 2019

    Report

    Report Number
    1030489-2019-01257
    Event Type
    Malfunction
    Date Received
    November 2, 2019
    Date of Event
    September 18, 2019
    Report Date
    December 8, 2019
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG #: 9393008, 510K #: K172199 AND UDI #: (B)(4) WAS CLEARED IN THE UNITED STATES. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTRA-OP, THE CAGE BROKE DURING IMPACTION. THE BROKEN CAGE WAS EXPLANTED; AND ANOTHER WAS PUT IN ITS PLACE WITHOUT ANY DIFFICULTY. PATIENT COMPLICATIONS WERE REPORTED TO BE UNKNOWN.

    Description of Event or Problem · 1

    THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SCOLIOSIS. THE SURGERY WAS PERFORMED AT L5-S1. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064414 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG NA 15HX

    Patients

    Seq Age Sex Outcome Treatment
    1