BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 24305305 · Received February 10, 2026

    Report

    Report Number
    3004785967-2026-00088
    Event Type
    Injury
    Date Received
    February 10, 2026
    Date of Event
    October 7, 2025
    Report Date
    February 10, 2026
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (BOXBOROUGH)
    Product Code
    OXO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A5) PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ENTRY A2) THIS VALUE REFLECTS THE MEAN AGE OF THE PATIENTS WHO UNDERWENT THE LUMBAR INTERBODY FUSION SURGERY AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A3) THIS VALUE REFLECTS THE MAJORITY GENDER OF THE PATIENTS WHO UNDERWENT THE LUMBAR INTERBODY FUSION SURGERY AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. B3) THE ARTICLE DID NOT PROVIDE THE DATE OF THE PROCEDURE. THE EVENT DATE PROVIDED IS THE PUBLISHED DATE. B5) THE ARTICLE CITATION IS INCLUDED. D4) THE SYSTEM PRODUCT NUMBER AND SERIAL NUMBER WERE NOT PROVIDED IN THE JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. G3) NO 510K PROVIDED AS SYSTEM IS UNKNOWN. H3) NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. H4) DEVICE MANUFACTURING DATE IS 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

    CITATION: SINGHATANADGIGE, W., LORWATTHANAKITCHAI, W., TANASANSOMBOON, T., KERR, S. J., YINGSAKMONGKOL, W., KOTHEERANURAK, V., <(>&<)> LIMTHONGKUL, W. (2025). OUTCOMES COMPARISON BETWEEN OBLIQUE LUMBAR INTERBODY FUSION AND MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION IN LOW-GRADE SPONDYLOLISTHESIS: A RANDOMIZED CLINICAL TRIAL. INTERNATIONAL JOURNAL OF SPINE SURGERY, 19(5), 578¿586. HTTPS://DOI.ORG/10.14444/8795 ABSTRACT: BACKGROUND: MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS-TLIF) AND OBLIQUE LUMBAR INTERBODY FUSION (OLIF) ARE WIDELY USED FOR TREATING SPONDYLOLISTHESIS PATIENTS, BUT THERE IS NO RANDOMIZED CONTROLLED TRIAL STUDY THAT DIRECTLY COMPARED OLIF AND MIS-TLIF. METHODS: SIXTY PATIENTS WHO UNDERWENT SINGLE-LEVEL SURGERY AT L4 TO L5 WERE RANDOMLY ALLOCATED TO THE MIS-TLIF OR OLIF GROUP. PRIMARY CLINICAL OUTCOMES WERE VISUAL ANALOG SCALE (VAS) OF BACK AND LEG PAIN, OSWESTRY DISABILITY INDEX (ODI) SCORES, AND EQ-5D-5L. SECONDARY OUTCOMES WERE RADIOLOGICAL OUTCOMES INCLUDING DISC HEIGHT (DH), FORAMINAL HEIGHT (FH), FORAMINAL AREA (FA), CROSS-SECTIONAL AREA OF SPINAL CANAL, SPINAL CANAL DIAMETER, AND FUSION RATES. RESULTS: BOTH GROUPS SHOWED SIGNIFICANT IMPROVEMENTS IN CLINICAL OUTCOMES FROM BASELINE TO EACH SUBSEQUENT POSTOPERATIVE PERIOD. PRE DICTED MEAN CHANGE (95% CI) IN VAS BACK, VAS LEG, ODI SCORES, AND EQ-5D-5L WERE -3.9 (-4.6 TO -3.1), -5.6 (-6.2 TO -5.1), -15.7 (-19.0 TO -12.5), AND 25.4 (21.3¿29.6), RESPECTIVELY. CLINICAL DIFFERENCES IN BOTH GROUPS OVER TOTAL FOLLOW-UP WERE NOT STATISTICALLY SIGNIFICANT: VAS BACK -0.38 (-0.87 TO 0.11); P = 0.18, VAS LEG: -0.40 (-0.81 TO 0.02); P = 0.08, ODI: 0.4 (-1.9 TO 2.8); P = 0.7 AND EQ-5D-5L: 0.1 (-1.9 TO 2.2); P = 0.9. RADIOLOGICAL PARAMETERS SIGNIFICANTLY IMPROVED FROM BASELINE TO EARLY POSTOPERATION IN BOTH GROUPS. CHANGES IN DH, FH, AND FA WERE LOWER IN MIS-TLIF COMPARED WITH OLIF. THE CROSS-SECTIONAL AREA OF SPINAL CANAL CHANGE WAS HIGHER IN MIS-TLIF COMPARED WITH OLIF. SPINAL CANAL DIAMETER CHANGE WAS NOT DIFFERENT BETWEEN GROUPS. FUSION RATES WERE SIMILAR IN BOTH GROUPS. CONCLUSIONS: PATIENT-REPORTED OUTCOMES WERE SIGNIFICANTLY IMPROVED IN BOTH MIS-TLIF AND OLIF GROUPS WITHOUT SIGNIFICANT DIFFERENCES BETWEEN BOTH PROCEDURES. OLIF DEMONSTRATED ADVANTAGES IN RESTORATION OF DH, FH, FA, AND LOWER INTRAOPERATIVE BLOOD LOSS COMPARED WITH MIS-TLIF. CLINICAL RELEVANCE: BOTH MIS-TLIF AND OLIF OFFER COMPARABLE CLINICAL BENEFITS FOR PATIENTS WITH SINGLE-LEVEL DEGENERATIVE SPONDYLOLISTHESIS. HOWEVER, OLIF MAY BE PREFERRED IN CASES WHERE GREATER RESTORATION OF DISC AND FORAMINAL DIMENSIONS AND REDUCED INTRAOPERATIVE BLOOD LOSS ARE DESIRED. REPORTED EVENT: 1. INCIDENTAL DUROTOMY OCCURRED IN TWO PATIENTS. ONE OF THE TWO PATIENTS DEVELOPED A NEW ONSET OF CONTRALATERAL RADICULOPATHY 2. FOUR PATIENTS HAD SYMPATHETIC CHAIN INJURY. 3. ANTERIOR THIGH PAIN, TRANSIENT PSOAS MUSCLE WEAKNESS, AND CONTRALATERAL LUMBAR RADICULOPATHY OCCURRED IN 3 DIFFERENT PATIENTS FO LLOWING THE OLIF PROCEDURE. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362848 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 63 YR Female Other