BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 2932837 · Received January 29, 2013

    Report

    Report Number
    1030489-2013-00281
    Event Type
    Death
    Date Received
    January 29, 2013
    Date of Event
    October 1, 2010
    Report Date
    January 2, 2013
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K081038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE CITATION: VINCENT C. TRAYNELIS, M.D., TOTAL SUBAXIAL RECONSTRUCTION. J NEUROSURG SPINE, 2010, VOLUME 13. DATE OF DEATH UNKNOWN.(B)(4). NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LITERATURE PUBLICATION THAT THE AUTHOR PERFORMED A REVIEW OF DATA PROSPECTIVELY COLLECTED IN 27 CONSECUTIVE PATIENTS UNDERGOING COMPLETE ANTERIOR DECOMPRESSION AND RECONSTRUCTION OF THE ANTERIOR CERVICAL SPINE AND FOLLOWED BY POSTERIOR INSTRUMENTED ARTHRODESIS WITH OR WITHOUT DECOMPRESSION. THERE WERE 16 MEN AND 11 WOMEN WHOSE MEAN AGE WAS (B)(6). THE MINIMUM FOLLOW-UP WAS 12 MONTHS AND THE MEAN FOLLOW-UP PERIOD FOR ALL PATIENTS WAS 26 MONTHS. ONE PATIENT UNDERWENT C2-7 SURGERY, AND IN ALL OTHERS THE PROCEDURE CROSSED THE CERVICOTHORACIC JUNCTION. DESPITE THE PRECONCEIVED TREATMENT PLAN TO PERFORM ONLY INTERSEGMENTAL DECOMPRESSION AND FUSION, IT WAS NECESSARY TO PERFORM CORPECTOMIES IN 2 PATIENTS. OVERALL, THE PATIENTS HAD THE TYPICAL COMORBIDITIES ONE WOULD EXCEPT FROM SUCH A TREATMENT POPULATION. TEN PATIENTS WERE SMOKERS. CUSTOM PLATES UP TO 130 MM IN LENGTH WERE USED IN MOST OF THE PATIENTS. SOME PATIENTS WERE TREATED WITH 2 PLATES DUE TO SIZE OR ANATOMICAL CONSTRAINTS. IN CONCLUSION, SEGMENTAL ANTERIOR DECOMPRESSION AND RECONSTRUCTION OF THE ENTIRE SUBAXIAL CERVICAL SPINE, COMBINED WITH AN INSTRUMENTED POSTEROLATERAL FUSION, CAN BE PERFORMED WITH ACCEPTABLE MORBIDITY AND IS OF SIGNIFICANT BENEFIT IN SELECTED PATIENTS. ONE PATIENT DIED 6 WEEKS FOLLOWING AN UNEVENTFUL SURGERY. PT. HAD A 43 DEGREE KYPHOSIS AND SIGNIFICANT MYELOPATHY. PT. HAD A HISTORY OF PULMONARY EMBOLI AND A SUPRAVENTRICULAR TACHYCARDIA. SHE WAS DISCHARGED ON POSTOPERATIVE DAY 3 AND UNDERWENT A BRIEF COURSE OF INTENSE THERAPY AT A REHABILITATION CENTER. NO AUTOPSY WAS PERFORMED AND THE CAUSE OF DEATH IS UNCLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39335 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDIC, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Death