BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 8236315 · Received January 10, 2019

    Report

    Report Number
    1030489-2019-00042
    Event Type
    Injury
    Date Received
    January 10, 2019
    Report Date
    October 5, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D4: PER THE IMPLANT LOG OF THE PATIENT, FOLLOWING IS THE UPDATED LIST OF PRODUCTS THAT WERE IMPLANTED IN THE PATIENT DURING THE SURGERY: 1. PRODUCT ID: 6287641, LOT #: H5382163, QTY.: 1, 510(K): K052931, UDI: (B)(4).2. PRODUCT ID: 6287841, LOT #: H5382163, QTY.: 1, 510(K): K052931, UDI: (B)(4). 3. PRODUCT ID: 7200065, LOT #: UNK, QTY.: 1, 510(K): K021461, UDI: (B)(4).4. PRODUCT ID: T43105, SERIAL #: (B)(4)., QTY.: 1, 510(K): K051195, UDI: (B)(4).5. PRODUCT ID: 6287641, LOT #: H5357587, QTY.: 1, 510(K): K052931, UDI: (B)(4).ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. 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.

    Description of Event or Problem · 0

    REPORTEDLY, THE DEVICES IMPLANTED IN THE PATIENT DID NOT BREAK BUT THE PATIENT CLAIMED TO HAVE "PROBLEMS" WITH HIS DEVICES.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: ( PRODUCT ID: 7200065; 510K : K021461; UDI#(B)(4) AND ( PRODUCT ID: 6287841; 510K: K052931; UDI#(B)(4). ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT UNSPECIFIED PROCEDURE. POST-OP, PATIENT SUFFERED FROM PAIN WHICH WORSENED 3-4 TIMES MORE THAN BEFORE SURGERY.THE PATIENT ALSO HAD BURNING PITCHING AND STINGING SENSATION IN HIS NECK AND WORSENED WHEN HE ROTATES THE NECK. X- RAY MRI DONE ON (B)(6) 2018 SHOWED C3, 4, 5, 6 ARE PROTRUDING BY 2MM AND PINCHING THE NERVES. PATIENT HAS PAIN RUNNING UP BOTH SIDES OF HIS NECK INTO JAWBONE AND EAR DRUMS; IT ALSO RUNS ACROSS HIS FACE, CHEEK BONES AND EYES. IT FEELS LIKE LOW VOLTAGE ELECTRIC CURRENT COMING ACROSS HIS FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29514 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDTRONIC SOFAMOR DANEK NA SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other