BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 21342372 · Received February 10, 2025

    Report

    Report Number
    1030489-2025-00663
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Date of Event
    July 19, 2023
    Report Date
    February 10, 2025
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWQ
    UDI-DI
    00763000868116
    PMA / PMN Number
    K063100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PART # 6190042, LOT # UNKNOWN - VISUAL AND OPTICAL INSPECTION CONFIRMED THE PLATES HAVE BEEN DAMAGED. THE LOCKING SCREWS HAVE BEEN STRIPPED AND THE EXPANDABLE PORTION OF THE PLATES HAS BROKEN. THE PLATES LOCKING SCREWS APPEAR TO HAVE BEEN STRIPPED DUE TO TORSIONAL OVERLOAD AND THE BROKEN PORTION DUE TO EXCESSIVE FORCE. 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 A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT TO BE IMPLANTED WITH PLATES IN AN ACDF FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT TWO PLATES BROKE WHEN COMPRESSING THE PLATE. IT WAS REPORTED THAT THERE WERE 2 BROKEN PLATES AND THEY CAME IN CONTACT WITH THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THE PLATES WERE NEVER IMPLANTED. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872374 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BOD KWQ WARSAW ORTHOPEDICS 6190042 UNKNOWN 00763000868116

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male