BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 22749400 · Received August 8, 2025

    Report

    Report Number
    1723170-2025-02934
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Date of Event
    June 2, 2025
    Report Date
    August 8, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    MIZUTANI, M., KOTANI, T., OGAWA, R., YANO, S., KISHIDA, S., OKUWAKI, S., OHYAMA, S., OGATA, Y., IIJIMA, Y., SAKUMA, T., ORITA, S., INAGE, K., SHIGA, Y., MINAMI, S., OHTORI, S. COMPARISON OF THE O-ARM-BASED NAVIGATION SYSTEM WITH CONVENTIONAL FLUOROSCOPY FOR PERCUTANEOUS SCREW FIXATION IN PATIENTS WITH FRAGILITY FRACTURES OF THE PELVIS. EUROPEAN JOURNAL OF TRAUMA AND EMERGENCY SURGERY. 2025. 51 (221). HTTPS://LINK.SPRINGER.COM/ARTICLE/10.1007/S00068-025-02901-Y PURPOSE FRAGILITY FRACTURES OF THE PELVIS (FFPS) ARE INCREASINGLY COMMON OWING TO AGING POPULATIONS OF SEVERAL COUNTRIES AND THE INCREASING OSTEOPOROSIS INCIDENCE. SURGICAL INTERVENTIONS, INCLUDING PERCUTANEOUS SCREW FIXATION, ARE PERFORMED TO AVOID COMPLICATIONS ASSOCIATED WITH PROLONGED BED REST FOR FFP MANAGEMENT. HOWEVER, CONVENTIONAL FLUOROSCOPY FOR SURGICAL NAVIGATION IS DIFFICULT OWING TO ISSUES SUCH AS INSUFFICIENT TISSUE IMAGING, DIFFICULTY ACHIEVING ACCURATE SCREW PLACEMENT, AND HIGH RADIATION EXPOSURE TO SURGEONS. THIS STUDY AIMED TO COMPARE THE EFFECTIVENESS OF THE O-ARM-BASED NAVIGATION SYSTEM WITH THAT OF CONVENTIONAL FLUOROSCOPY FOR PERCUTANEOUS SCREW FIXATION IN PATIENTS WITH FFPS, FOCUSING ON SURGICAL OUTCOMES, RADIATION EXPOSURE, AND SCREW-PLACEMENT ACCURACY. METHODS THIS RETROSPECTIVE MULTICENTER STUDY WAS CONDUCTEDBETWEEN APRIL 2020 AND MAY 2024. SEVENTY-TWO PATIENTS WITH FFPS WERE DIVIDED INTO TWO GROUPS: O-ARM (O, N=14) AND THE CONVENTIONAL FLUOROSCOPY (C, N=58) GROUPS. PRIMARY EVALUATION PARAMETERS WERE RADIATION EXPOSURE AND SCREW-PLACEMENT ACCURACY. DEMOGRAPHIC AND SURGICAL DATA, INCLUDING SURGERY DURATION AND INTRAOPERATIVE BLOOD LOSS, WERE COLLECTED FOR SECONDARY EVALUATION. RESULTS THERE WAS NO SIGNIFICANT DIFFERENCES IN DEMOGRAPHIC DATA BETWEEN GROUPS. SURGEON RADIATION EXPOSURE WAS LOWER IN THE O GROUP (0.1¿0.2 SV) THAN IN THE C GROUP (MEAN EXPOSURE: 109.8±61.3 MGY). THE SCREW-PERFORATION RATE WAS LOWER IN THE O GROUP (5.7%) THAN IN THE C GROUP (20%). NO PATIENTS IN THE O GROUP REQUIRED REOPERATION; HOWEVER, THREE PATIENTS IN THE C GROUP DID. CONCLUSION COMPARED WITH CONVENTIONAL FLUOROSCOPY, THE O-ARM-BASED NAVIGATION SYSTEM IMPROVES SCREW-PLACEMENT ACCURACY AND SIGNIFICANTLY REDUCES SURGEON RADIATION EXPOSURE. REPORTABLE EVENTS: ONE GRADE 1 PERFORATION ONE GRADE 2 PERFORATION SCREW PERFORATION RATE WAS 5.7% ALL THE SCREW PERFORATIONS WERE CAUSED BY SUPERIOR PUBLIC RAMUS SCREW (SPRS) TWO CASES INVOLVED SCREWS FOLLOWING AN IN-OUT-IN TRAJECTORY THROUGH THE CORTICAL BONE, BUT WITHOUT BREACHING ANY CRITICAL STRUCTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223288 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown