BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 11891852 · Received May 27, 2021

    Report

    Report Number
    1030489-2021-00700
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    May 19, 2021
    Report Date
    September 23, 2021
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWQ
    UDI-DI
    00613994625182
    PMA / PMN Number
    K021461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3:PART# 7200025 , LOT# 0756408W, VISUAL AND OPTICAL EXAMINATION CONFIRMED THE PLATE WAS RETURNED DAMAGED. ONE OF THE LOCKING PLATE CAPS HAS BEEN SEPARATED FROM THE PLATE. OPTICAL INSPECTION CONFIRMED WITNESS MARKS AND MATERIAL DEFORMATION ON THE LOCKING CAP CONSISTENT WITH OVERLOAD. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    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

    INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, FOREIGN) REGARDING A PATIENT WITH CERVICAL SPONDYLOSIS PLUS THORACIC SPINE FRACTURE FOR ANTERIOR CERVICAL INTERNAL FIXATION SPINAL THERAPY. IT WAS REPORTED THAT THE IMPLANTATION IS ALMOST COMPLETE, AND IT FALLS OFF WHEN LOCKED, AND THEN THERE IS NO OTHER WAY BUT TO TAKE IT OUT. THE LOCKING MECHANISM IS BROKEN. THE EVENT DIDN'T CAUSE THE PATIENT TO EXPERIENCE SYMPTOMS OR COMPLICATIONS. DIRECTLY CHANGED TO AN ELITE BOARD OF THE SAME TYPE (THE SIZE IS ONE SIZE LARGER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794467 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BOD KWQ WARSAW ORTHOPEDICS 7200025 0756408W 00613994625182

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR