BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 22469302 · Received July 10, 2025

    Report

    Report Number
    3004785967-2025-00488
    Event Type
    Injury
    Date Received
    July 10, 2025
    Date of Event
    April 21, 2025
    Report Date
    July 10, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (BOXBOROUGH)
    Product Code
    OXO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. A3) PATIENT GENDER IS THE MAJORITY VALUE OF PATIENT IN THE STUDY. A4) PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. B3) EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. D4) DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. G4) 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. H3, H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. H4) DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    YANG, Y., ZHOU, Q., PU, X., ZHANG, Z., SUN, K., WANG, B., ZHU, Z., QIU, Y., SUN, X. O-ARM NAVIGATED MIS-TLIF AVOIDS VIOLATION AND DELAYS DEGENERATION OF THE SUPRADJACENT FACET JOINT. ORTHOPAEDIC SURGERY. 2025. 17(1710-1720). HTTPS://DOI.ORG/10.1111/OS.70044 OBJECTIVE O-ARM NAVIGATED MIS-TLIF IS ONE OF THE NOVEL SURGICAL TECHNIQUES FOR TREATING LUMBAR SPONDYLOLISTHESIS, BUT THERE STILL LACKS ENOUGH EVIDENCE REGARDING INTRAOPERATIVE FACET JOINT VIOLATION (FJV) AND POSTOPERATIVE FACET JOINT DEGENERATION (FJD). THIS STUDY AIMED TO COMPARE CLINICAL OUTCOMES, ACCURACY OF SCREW PLACEMENT, AND SUPRADJACENT FJV BETWEEN THE O-ARM NAVIGATED MIS-TLIF GROUP (NAVMIS-TLIF GROUP) AND THE OPEN-TLIF GROUP FOR THE TREATMENT OF LOW-GRADE LUMBAR SPONDYLOLISTHESIS, AND FURTHER, TO INVESTIGATE THE RISK FACTORS INFLUENCING FJD. METHODS WE RETROSPECTIVELY REVIEWED A COHORT OF PATIENTS WITH LOW-GRADE LUMBAR SPONDYLOLISTHESIS WHO HAD RECEIVED O-ARM NAVIGATED MIS-TLIF OR OPEN TLIF FROM MAY 2018 TO MAY 2023. ALL THE PATIENTS WERE FOLLOWED UP FOR AT LEAST 1 YEAR. THE DEMOGRAPHIC AND PERIOPERATIVE DATA WERE RECORDED. THE ODI AND VAS SCORES WERE COLLECTED BEFORE SURGERY, 3 MONTHS POSTOPERATIVELY, AND AT THE FINAL FOLLOW-UP. SLIP PARAMETERS WERE MEASURED BEFORE SURGERY AND AT THE LAST FOLLOW-UP. THE SCREW CONVERGENCE ANGLE AT THE UPPER INSTRUMENTED VERTEBRA WAS EVALUATED BASED ON POSTOPERATIVE CT IMAGES. ACCURACY OF SCREW PLACEMENT AND SUPRADJACENT FJV WERE ASSESSED AFTER SURGERY. THE FJD WAS ASSESSED AT THE FINAL FOLLOW-UP IN COMPARISON TO THAT BEFORE SURGERY. RESULTS EACH GROUP HAD 42 PATIENTS. VAS BACK PAIN OF THE NAVMIS-TLIF GROUP AT THE 3-MONTH FOLLOW-UP WAS LOWER THAN THAT OF THE OPEN-TLIF GROUP, YET THERE WAS NO SIGNIFICANT DIFFERENCE IN ODI AND VAS SCORES BETWEEN THE GROUPS AT THE FINAL FOLLOW-UP. BOTH GROUPS HAD SIMILAR SLIP REDUCTION RESULTS. THE CLINICALLY ACCURATE RATE OF SCREW PLACEMENT IN THE NAVMIS-TLIF GROUP WAS 99.4%, SIGNIFICANTLY HIGHER THAN 94.0% IN THE OPEN-TLIF GROUP. AT THE UPPER INSTRUMENTED VERTEBRA, THE SCREW CONVERGENCE ANGLE OF THE NAVMIS-TLIF GROUP WAS SIGNIFICANTLY LARGER THAN THAT OF THE OPEN-TLIF GROUP. THE INCIDENCE OF FJV IN THE NAVMIS-TLIF GROUP (23.8%) WAS SIGNIFICANTLY LOWER THAN THAT IN THE OPEN-TLIF GROUP (53.6%). THERE WAS NO SIGNIFICANT DIFFERENCE IN PREOPERATIVE FJD BETWEEN THE TWO GROUPS, WHILE AT THE LAST FOLLOW-UP, THE OPEN-TLIF GROUP HAD MORE CASES OF FJD. THE SCREW CONVERGENCE ANGLE HAD A NEGATIVE CORRELATION WITH FJV AND THE AGGRAVATION OF FJD, AND FJV WAS POSITIVELY ASSOCIATED WITH THE AGGRAVATION OF FJD. MULTIVARIABLE LOGISTIC REGRESSION SHOWED THAT FJV SERVED AS AN INDEPENDENT RISK FACTOR FOR THE AGGRAVATION OF FJD. CONCLUSIONS O-ARM NAVIGATED MIS-TLIF HAS SIMILAR CLINICAL OUTCOMES AND HIGHER ACCURACY OF SCREW PLACEMENT COMPARED TO OPEN TLIF. O-ARM NAVIGATED MIS-TLIF REDUCES THE INCIDENCE OF FJV SIGNIFICANTLY, WHICH PROBABLY HELPS TO DELAY FJD. REPORTABLE EVENTS: NAVMIS-TLIF GROUP: 15 SCREWS WITH TYPE II VIOLATION AND 5 SCREWS WITH TYPE III VIOLATION OPEN-TLIF GROUP: THERE WERE 25 SCREWS WITH TYPE II VIOLATION AND 20 SCREWS WITH TYPE III VIOLATION NAVMIS-TLIF GROUP COMPLICATION: TEMPORARY SUBMUSCULAR HEMATOMA IN ONE PATIENT. OPEN-TLIF GROUP COMPLICATION: THERE WAS ONE CASE OF AN INCIDENTAL DURAL TEAR, WHICH RECEIVED SUTURE REPAIR INTRAOPERATIVELY, AND ONE CASE WITH A SUPERFICIAL TISSUE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729938 O-ARM IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M OXO MEDTRONIC NAVIGATION, INC. (BOXBOROUGH) UNK_OARM_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention