BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 21362389 · Received February 12, 2025

    Report

    Report Number
    1030489-2025-00748
    Event Type
    Malfunction
    Date Received
    February 12, 2025
    Date of Event
    November 2, 2023
    Report Date
    February 12, 2025
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWQ
    UDI-DI
    00763000868123
    PMA / PMN Number
    K063100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PART# 6190045, LOT# 0788636W VISUAL AND OPTICAL INSPECTION CONFIRMED ONE OF THE EXTENDERS ENDS OF THE CERVICAL PLATES HAS BROKEN. THE DAMAGE APPEARS TO BE FROM EXCESSIVE FORCE PLACED ON THE IMPLANT DURING USE. H11: THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN A NTERIOR C5-C7 DISCECTOMIES AND FUSION SPINAL THERAPY FOR CERVICAL SPONDYLOSIS, STENOSIS, AND MYELOPATHY. LEVELS IMPLANTED WAS C5-7. IT WAS REPORTED THE SURGEON BENT IT SOME WITH HIS HANDS WERE NOT SUPPOSED TO BE BENT BUT THAT THEY DO HAVE SOME FLEX AND THEN PUT IT IN THE WOUND. UPON DOING THE FINAL TIGHTENING OF ALL 6 SELF-DRILLING FIXED ANGLE SCREWS THE PLATE DISTRACTED AND BROKE. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847055 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BOD KWQ WARSAW ORTHOPEDICS 6190045 0788636W 00763000868123

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male