BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 14982154 · Received July 11, 2022

    Report

    Report Number
    3004785967-2022-00453
    Event Type
    Injury
    Date Received
    July 11, 2022
    Date of Event
    February 21, 2022
    Report Date
    July 11, 2022
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OXO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ENTRY. AGE OR DATE OF BIRTH: THIS VALUE REFLECTS THE MEAN AGE OF THE PATIENTS WHO UNDERWENT THE ANTERIOR CERVICAL DISKECTOMY AND FUSION AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX: THIS VALUE REFLECTS THE MAJORITY GENDER OF THE PATIENTS WHO UNDERWENT THE ANTERIOR CERVICAL DISKECTOMY AND FUSION AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THE ARTICLE DID NOT PROVIDE THE DATE OF THE PROCEDURE. THE EVENT DATE PROVIDED IS THE ACCEPTED DATE. THE ARTICLE CITATION IS INCLUDED. THE SYSTEM PRODUCT NUMBER AND SERIAL NUMBER WERE NOT PROVIDED IN THE JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. NO 510K PROVIDED AS SYSTEM IS UNKNOWN. NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. DEVICE MANUFACTURING DATE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    NIE, J. Z., WEBER, M. W., REVELT, N. J., NORDMANN, N. J., WATSON, V. L., NIE, J. W., MENEZES, S. A., DELFINO, K., COZZENS, J. W., ESPINOSA, J. A., AMIN, D., <(>&<)>AMP; ACAKPO-SATCHIVI, L. (2022). COMPARISON OF USING INTRAOPERATIVE COMPUTED TOMOGRAPHY¿BASED 3-DIMENSIONAL NAVIGATION AND FLUOROSCOPY IN ANTERIOR CERVICAL DISKECTOMY AND FUSION FOR CERVICAL SPONDYLOSIS. WORLD NEUROSURGERY, 161. HTT PS://DOI.ORG/10.1016/J.WNEU.2022.02.089 SUMMARY: OBJECTIVE: ANTERIOR CERVICAL DISKECTOMY AND FUSION (ACDF) IS A HIGHLY SUCCESSFUL PROCEDURE TO TREAT SPINAL CORD OR NERVE ROOT COMPRESSION; HOWEVER, COMPLICATIONS CAN STILL OCCUR. WITH ADVANCEMENTS IN IMAGING, 3-DIMENSIONAL (3D) RECONSTRUCTION ALLOWS REAL-TIME INSTRUMENT TRACKING IN A SURGICAL FIELD RELATIVE TO THE PATIENT¿S ANATOMY. HERE, WE COMPARE PLATE POSITIONING AND SHORT-TERM OUTCOMES WHEN USING 3D NAVIGATION TO FLUOROSCOPY IN ACDF FOR DEGENERATIVE SPINE DISEASE. METHODS: ALL ACDFS FOR CERVICAL SPONDYLOSIS PERFORMED BY 6 SURGEONS AT A SINGLE CENTER BETWEEN 2010 AND 2018 WERE INCLUDED. ACDFS WERE DIVIDED INTO THOSE PERFORMED USING 3D NAVIGATION OR FLUOROSCOPY. RECORDS WERE ASSESSED FOR PATIENT DEMOGRAPHICS, AMERICAN SOCIETY OF ANESTHESIOLOGY SCORE, NUMBER OF OPERATED INTERSPACES, OPERATIVE TIME, LENGTH OF STAY, PERIOPERATIVE COMPLICATIONS, AND 90-DAY READMISSIONS. POSTOPERATIVE IMAGES WERE REVIEWED FOR LATERAL AND ANGULAR PLATE DEVIATIONS. RESULTS: A TOTAL OF 193 ACDFS PERFORMED WITH 3D NAVIGATION AND 728 PERFORMED WITH FLUOROSCOPY WERE INCLUDED. AFTER CONTROLLING FOR D EMOGRAPHICS AND SURGICAL CHARACTERISTICS, USING 3D NAVIGATION WAS ASSOCIATED WITH LESS LATERAL PLATE DEVIATION (P [ 0.048) AND LONGER OPERATIVE TIMES PER INTERSPACE (P <(><<)> 0.001) BUT WAS NOT ASSOCIATED WITH ANGULAR PLATE DEVIATION (P [ 0.724), LENGTH OF STAY (P [ 0.393), PERIOPERATIVE COMPLICATIONS (P [ 0.844), AND 90-DAY READMISSIONS (P [ 0.539). CONCLUSIONS: USING 3D NAVIGATION IN ACDF FOR DEGENERATIVE DISEASE IS ASSOCIATED WITH SLIGHTLY MORE MIDLINE PLATE POSITIONING AND COMPARABLE SHORT-TERM OUTCOMES AS USING FLUOROSCOPY AND CAN BE A SUITABLE ALTERNATIVE. ADVANTAGES OF USING THIS TECHNOLOGY, SUCH AS IMPROVED VISUALIZATION OF ANATOMY, SHOULD BE WEIGHED AGAINST DISADVANTAGES, SUCH AS INCREASED OPERATIVE TIME, ON A PER-PATIENT BASIS. REPORTED EVENT: ONE HUNDRED AND NINETY-THREE PATIENTS WITH AHISTOLOGY OF SPINAL CORD OR NERVE ROOT COMPRESSION UNDERWENT ANTERIOR CERVICAL DISKECTOMY AND FUSION (ACDF). PERIOPERATIVELY, NINE PATIENTS HAD DYSPHAGIA AND/OR DYSPHONIA. POST-OPERATIVELY, ISSUES DEVELOPED CAUSING PATIENTS TO BE READMITTED WITHIN 90 DAYS OF THE PROCEDURE. THERE WAS ONE CASE OF HEMATOMA, ONE INFECTION( NOT LOCATED ON THE SURGICAL SITE), TWO CASES OF WEAKNESS, SYNCOPE, AND/OR UNSTEADINESS, ONE PULMONARY PROBLEM, AND ONE PSYCHIATRIC PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028568 O-ARM IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M OXO MEDTRONIC NAVIGATION, INC (LITTLETON) UNK_OARM_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Other