BEUDAMED
    FDA Adverse Event Death Summary report: N

    OARM 1000 IMAGING SYSTEM

    MDR report key: 8000504 · Received October 24, 2018

    Report

    Report Number
    1723170-2018-05323
    Event Type
    Death
    Date Received
    October 24, 2018
    Date of Event
    April 10, 2018
    Report Date
    October 24, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH WAS NOT REPORTED IN THE ARTICLE. SERIAL NUMBER PROVIDED FOR THE SYSTEM MOST LIKELY TO HAVE BEEN USED IN THE STUDY AT THE HOSPITAL, IT WAS NOT PROVIDED IN THE ARTICLE. THERE WAS NO DEVICE EVALUATION BECAUSE THERE WAS NO ALLEGATION OF A MALFUNCTION OF THE SYSTEM. REFERENCE MDR 1723170-2018-05322 FOR THE NAVIGATION SYSTEM USED IN THE STUDY/ARTICLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUBJECT: LITERATURE: OULD-SLIMANE EVENT DESCRIPTION: CITATION: OULD-SLIMANE M. FERRACCI F. LE PAPE S. ET AL. POSTERIOR C1C2 HARMS FUSION WITH 3D SURGICAL NAVIGATION. (2018). ORTHOPAEDICS <(>&<)> TRAUMATOLOGY: SURGERY <(>&<)> RESEARCH 104 (2018) 585¿588. HTTPS://DOI.ORG/10.1016/J.OTSR.2018.04.012 ABSTRACT: SEVERAL TYPES OF ATLANTOAXIAL INSTABILITY CAN JUSTIFY SURGICAL FIXATION. THE INSTRUMENTED FUSION PROCEDURE DESCRIBED BY HARMS WITH SCREW FIXATION OF THE C1 LATERAL MASSES AND C2 PEDICLES IS A DEMANDING TECHNIQUE THAT PROVIDES LASTING STABILIZATION. HOWEVER, IT HAS BEEN ASSOCIATED WITH NERVE AND VASCULAR COMPLICATIONS DUE TO THE LOCAL ANATOMICAL CONFIGURATION. SURGICAL NAVIGATION SYSTEMS CAN HELP IMPROVE THE PROCEDURE¿S ACCURACY. WE DESCRIBE A SERIES OF 11 CASES OF C1C2 HARMS FUSION PERFORMED WITH SURGICAL NAVIGATION AND INTRAOPERATIVE 3D IMAGING CHECKS. ALL PROCEDURES WERE CARRIED OUT COMPLETELY WITH SATISFACTORY IMPLANT PLACEMENT. THERE WERE NO ADVERSE EVENTS RELATED TO THE PROCEDURE DURING THE PERI-OPERATIVE PERIOD. NO CORTICAL BREACH WAS DETECTED USING CONE-BEAM CT AT THE END OF THE PROCEDURE. THE TECHNICAL CHALLENGES AND RISKS ASSOCIATED WITH C1C2 HARMS FUSION HAVE LED TO THE USE OF 3D INTRAOPERATIVE IMAGING SYSTEMS, WHEN AVAILABLE. REPORTED ADVERSE EVENT: PATIENT 8 (B)(6) FEMALE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843230 OARM 1000 IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC BI70000027230

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death