BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 12285843 · Received August 6, 2021

    Report

    Report Number
    1030489-2021-01021
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    July 19, 2021
    Report Date
    December 9, 2021
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWQ
    UDI-DI
    00613994235695
    PMA / PMN Number
    K063100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. PRODUCT ANALYSIS PRODUCT ID: 6190062, LOT ID: 0569216W. VISUAL AND OPTICAL INSPECTION CONFIRMED THE END COMPONENT PLATE HAS SEPARATED FROM THE MAIN PLATE. OPTICAL INSPECTION CONFIRMED THE RATCHET SPRING IS MISSING. THIS COMPONENT HOLDS THE END PLATE TO THE MAIN PLATE. IT APPEARS THE PLATE WAS OVERLOADED CAUSING THE END PLATE TO SEPARATE. IT APPEARS THAT ONE OF THE PLATES FEMALE END HAS BEEN DAMAGED WHERE IT MEETS THE RATCHET SPRING. THIS IS CONSISTENT WITH OVERLOAD. 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

    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 VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR CERVICAL RADICULOPATHY AND STENOSIS. PROCEDURE PERFORMED WAS ACDF. IT WAS REPORTED THAT DURING IMPLANTATION OF THE PLATE, FORCE WAS USED TO SCREW THE BONE SCREW THROUGH THE PLATE INTO THE PATIENTS BONE. UPON RADIOGRAPHIC VERIFICATION OF THE IMPLANT, IT WAS DEEMED THAT THE IMPLANTED PLATE LOOKED LIKE A TRANSLATING JOINT HAD DISCONNECTED ON ONE SIDE OF THE PLATE. THE PLATE WAS EXAMINED BY THE SURGEON, EXPLANTED, AND A NEW IMPLANT WAS USED. THERE WAS NO PATIENT INJURY FROM THIS EVENT. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. NO ANY TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. SHORT DELAY OF APPROXIMATELY 10 MINUTES TO REMOVE INITIAL PLATE, SELECT AND IMPLANT NEW PLATE, AND PERFORM RADIOGRAPHIC CONFIRMATION. INITIAL IMPLANTATION, EXPLANATION A NEW IMPLANT INSERTED IN A SAME SURGERY. THE ACTUAL DEVICE CAME APART IN TWO PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182899 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDICS 6190062 0569216W 00613994235695

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male