BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 22976804 · Received September 5, 2025

    Report

    Report Number
    3004785967-2025-00598
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Date of Event
    July 21, 2025
    Report Date
    September 5, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (BOXBOROUGH)
    Product Code
    OXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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

    ARETAKIS, A., ADAMS, J., MARTINO, R., CARRY, P., STICKEL, J., HADLEY-MILLER, N., GEORGOPOULOS, G., SELBERG, C. NOVEL USE OF THE O-ARM FOLLOWING OPEN REDUCTION OF A DISLOCATED HIP FOR A WALKING AGE PATIENT PROVIDES A LOW-RADIATION ALTERNATIVE TO CT. JOURNAL OF PEDIATRIC ORTHO. 2025. 1;45(8):474-480. DOI: 10.1097/BPO.0000000000003003 BACKGROUND: SURGICAL TREATMENT OF A DISLOCATED HIP AT WALKING AGE INCLUDES OPEN REDUCTION (OR) WITH OR WITHOUT OSTEOTOMIES OF THE PELVIS AND/OR FEMUR. THREE-DIMENSIONAL IMAGING, SUCH AS COMPUTERIZED TOMOGRAPHY (CT), CAN BE UTILIZED POSTOPERATIVELY TO DETERMINE FEMORAL HEAD POSITION FOLLOWING CAST PLACEMENT. ALTERNATIVELY, INTRAOPERATIVE 3D IMAGING (O-ARM) MAY BE USED FOR THE SAME PURPOSE. DISADVANTAGES OF CT INCLUDE LIMITED ACCESS TO THE PATIENT'S AIRWAY AND HIGH RADIATION DOSE. THE CURRENT STUDY AIMED TO DETERMINE THE ABILITY OF O-ARM IMAGING TO VISUALIZE FEMORAL HEAD POSITION FOLLOWING SURGICAL TREATMENT OF A DISLOCATED HIP, AND COMPARE RADIATION DOSAGE BETWEEN CT AND O-ARM. METHODS: THIRTEEN PATIENTS (16 HIPS) WITH A DISLOCATED HIP AT WALKING AGE WHO UNDERWENT OR WITH PELVIC ± FEMORAL OSTEOTOMIES AT A SINGLE INSTITUTION WERE RETROSPECTIVELY REVIEWED. ALL PATIENTS UNDERWENT CT OR O-ARM EVALUATION FOLLOWING SURGERY AND SPICA CAST APPLICATION. TOTAL RADIATION DOSE PER KILOGRAM WAS COMPARED BETWEEN THE CT (N=8 HIPS) AND O-ARM 14 (N=8 HIPS) GROUPS. RADIOGRAPHIC PARAMETERS AND COMPLICATION RATES WERE ANALYZED. IMAGE QUALITY WAS BLINDLY ASSESSED BY 3 FELLOWSHIP-TRAINED PEDIATRIC ORTHOPEDIC SURGEONS WITH HIP EXPERTISE. RESULTS: THE MEAN AGE WAS 4.68 YEARS (RANGE: 3.1-7.8) IN THE CT GROUP AND 4.31 (RANGE: 1.2-7.5) IN THE O-ARM GROUP. THE AVERAGE RADIATION DOSE FROM THE O-ARM WAS LOWER THAN CT (4.51 19 MGY/KG VS. 6.12 MGY/KG, P =0.37). FIVE HIPS IN THE CT COHORT WERE SCANNED POST-EXTUBATION. ALL SURGEONS AGREED THAT FEMORAL HEAD POSITION WAS ADEQUATELY VISUALIZED IN ALL IMAGES FROM BOTH GROUPS. NO PATIENT IN EITHER GROUP REQUIRED A CAST CHANGE POST-SCANNING DUE TO A MALPOSITIONED FEMORAL HEAD. CONCLUSION: THE O-ARM IS A REASONABLE ALTERNATIVE TO CT FOLLOWING SURGICAL TREATMENT OF A DISLOCATED HIP. IT MAY DECREASE RADIATION DOSE AND PROVIDES ADEQUATE VISUAL INFORMATION TO DETERMINE FEMORAL HEAD POSITION FOLLOWING SURGICAL INTERVENTION AND CASTING. UTILIZATION OF THE O-ARM KEEPS THE PATIENT IN THE OPERATING ROOM DURING THE STUDY, ALLOWING FOR IMMEDIATE REVISION OF THE CAST POSITION OR REVISION REDUCTION IF NECESSARY, WHILE MAXIMIZING ACCESS TO THE PATIENT'S AIRWAY AND MINIMIZING RISK FOR ADVERSE ANESTHETIC EVENTS. REPORTED EVENTS: IT SHOULD BE NOTED THAT AVN OCCURRED FOLLOWING A SUBSEQUENT SURGICAL PROCEDURE IN THE PATIENT FROM THE O-ARM GROUP. THE PATIENT SUSTAINED A SUBTROCHANTERIC FEMUR FRACTURE THROUGH A SCREW HOLE SHORTLY AFTER UNDERGOING PLANNED HARDWARE REMOVAL AND UNDERWENT SUBSEQUENT SURGICAL FIXATION OF THE FEMUR FRACTURE. AVN WAS NOTED ON IMAGING 2 MONTHS AFTER THIS PLATING PROCEDURE, 9 MONTHS AFTER THE ORIGINAL HIP OPEN REDUCTION. IT IS DIFFICULT TO ASCERTAIN WHAT TRULY CAUSED AVN IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321993 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 4 YR Female