BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 7261928 · Received February 9, 2018

    Report

    Report Number
    1030489-2018-00200
    Event Type
    Malfunction
    Date Received
    February 9, 2018
    Date of Event
    January 11, 2018
    Report Date
    February 9, 2018
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR SALE IN US BUT A SIMILAR PRODUCT WITH CATALOG # 9392507, UPN (B)(4) AND 510K# K172199 IS APPROVED FOR SALE IN US. 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.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: KYPHOSIS. TYPE OF PROCEDURE OR TECHNIQUE USED: TRANSFORAMINAL LUMBAR INTERBODY FUSION LEVELS IMPLANTED: L5/S. IT WAS REPORTED THAT INTRA-OP, THE MARKER DEVIATED AND END OF THE CAGE BREAKAGE WAS NOTICED WHEN CONFIRMING IT WITH IMAGE. THE BROKEN PIECE WAS RETRIEVED AND THE MARKER WAS DISCARDED IN FACILITY. BROKEN CAGE WAS INDWELT IN THE PATIENT¿S BODY DIRECTLY AND THE OPERATION WAS COMPLETED. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103560 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG NA 21CN

    Patients

    Seq Age Sex Outcome Treatment
    1