BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 10256627 · Received July 10, 2020

    Report

    Report Number
    1030489-2020-00868
    Event Type
    Malfunction
    Date Received
    July 10, 2020
    Date of Event
    June 18, 2020
    Report Date
    July 10, 2020
    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

    SIMILAR DEVICE WITH PRODUCT NUMBER - 9392507, PRODUCT DESCRIPTION - CRESCENT¿ SPINAL SYSTEM 25X7 IS MARKETED IN US WITH 510(K)# - K172199. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT SPINAL THERAPY FOR HE RNIA. IT WAS REPORTED THAT A CAGE WITH A HEIGHT OF 7 MM WAS USED. SINCE THE INTERVERTEBRAL DISC SPACE WAS ORIGINALLY NARROW, THE DISTRACTION WAS PERFORMED UNTIL 8MM, AND THE TRIAL WAS PLACED WITHOUT PROBLEMS. A METAL HAMMER WAS USUALLY USED TO HIT THE CAGE, BUT A PLASTIC HAMMER WAS USED THIS TIME. SINCE IT WAS BROKEN AND DAMAGED AROUND THE POSTERIOR WALL, THE CAGE WAS REMOVED IMMEDIATELY. THERE WAS PATIENT INVOLVED IN THIS EVENT. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725431 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG 9392507INT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR