BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 18467213 · Received January 8, 2024

    Report

    Report Number
    3004785967-2024-00016
    Event Type
    Malfunction
    Date Received
    January 8, 2024
    Date of Event
    November 2, 2023
    Report Date
    January 8, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OXO
    Product Problem
    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 IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    DENG, H., CONG, Y., LEI, J., LI, D., KE, C., FAN, Z., WANG, H., WANG, P., ZHUANG, Y. EFFECT OF O-ARM ON REDUCTION QUALITY AND FUNCTIONAL RECOVERY OF ACETABULAR DOME IMPACTION FRACTURES: A RETROSPECTIVE CLINICAL STUDY. BMC MUSCULOSKELETAL DISORDERS. 2023. 24(858) HTTPS://DOI.ORG/10.1186/S12891-023-06987-6 ABSTRACT BACKGROUND ACETABULAR DOME IMPACTION FRACTURES (ADIF) ARE DIFFICULT TO REDUCE AND HAVE A HIGH FAILURE RATE. CONSISTENCY BETWEEN THE ACETABULUM AND THE FEMORAL HEAD IS USUALLY ASSESSED USING INTRAOPERATIVE X-RAY FLUOROSCOPY TO EVALUATE THE QUALITY OF FRACTURE REDUCTION. THIS STUDY EXAMINES THE EFFECTS OF INTRAOPERATIVE MOBILE 2D/3DX IMAGING SYSTEM (O-ARM) ON THE REDUCTION QUALITY AND FUNCTIONAL RECOVERY OF ADIF. METHODS WE RETROSPECTIVELY ANALYSED THE DATA OF 48 PATIENTS WITH ADIF TREATED AT (B)(6) HOSPITAL BETWEEN (B)(6) 2018 AND (B)(6) 2021.THE PATIENTS WERE DIVIDED INTO THE X-RAY AND O-ARM GROUPS. THE RESIDUAL STEP-OFF AND GAP DISPLACEMENTS IN THE ACETABULAR DOME REGION WERE MEASURED, AND FRACTURE REDUCTION QUALITY WAS EVALUATED. HIP FUNCTION WAS EVALUATED USING THE MODIFIED MERLE D¿AUBIGNÉ AND POSTEL SCORING SYSTEMS. RESULTS THERE WERE NO SIGNIFICANT INTERGROUP DIFFERENCES IN THE PREOPERATIVE GENERAL DATA (P > 0.05). THE MEAN RESIDUAL AVERAGE STEP DISPLACEMENT IN THE ACETABULAR DOME REGION WAS 3.48 ± 2.43 MM AND 1.61 ± 1.16 MM (P <(><<)> 0.05), WHILE THE MEAN GAP DISPLACEMENT WAS 6.72 ± 3.69 MM AND 3.83 ± 1.67 MM (P <(><<)> 0.05) IN THE X-RAY AND THE O-ARM GROUPS, RESPECTIVELY. IN THE X-RAY GROUP, ACCORDING TO THE FRACTURE REDUCTION CRITERIA DESCRIBED BY VERBEEK AND MOED ET AL., ONE CASE WAS EXCELLENT, 13 CASES WERE GOOD, 11 CASES WERE POOR; 56% WERE EXCELLENT OR GOOD. IN THE O-ARM GROUP, SEVEN CASES WERE EXCELLENT, 12 CASES WERE GOOD, AND FOUR CASES WERE POOR; OVERALL IN THIS GROUP, 82.6% WERE EXCELLENT OR GOOD (P <(><<)> 0.05). A TOTAL OF 46 PATIENTS ACHIEVED FRACTURE HEALING AT THE LAST FOLLOW-UP. IN THE X-RAY GROUP, ACCORDING TO THE MODIFIED MERLE D¿AUBIGNÉ AND POSTEL FUNCTION SCORE, THREE CASES WERE EXCELLENT,12 CASES WERE GOOD, SIX CASES WERE MIDDLE, THREE CASES WERE POOR; 62.5% WERE EXCELLENT OR GOOD, IN THE O-ARM GROUP, 15 CASES WERE EXCELLENT, FOUR CASES WERE GOOD, TWO CASES WERE MIDDLE, ONE CASE WAS POOR; 86.4% WERE EXCELLENT OR GOOD (P <(><<)> 0.05). CONCLUSIONS THE APPLICATION OF O-ARM IN ADIF CAN IMPROVE FRACTURE REDUCTION QUALITY AND FUNCTIONAL RECOVERY. REPORTED EVENT: THE OARM HAD 4 POOR CASES THE OARM MERLED'AUBIGNE© AND POSTEL FUNCTION SCORE HAD ONE CASE THAT WAS POOR THE OARM HAD ONE CASE WITH OSTEOARTHRITIS SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568366 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 61 YR Male