BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 11922904 · Received June 2, 2021

    Report

    Report Number
    1723170-2021-01466
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Date of Event
    September 12, 2020
    Report Date
    June 2, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ARTICLE. THIS VALUE REFLECTS THE AVERAGE AGE OF THE PATIENTS IN THE ARTICLE SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS IN THE ARTICLE SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS PUBLISHED ONLINE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. ARTICLE CITATION IS INCLUDED. SYSTEM SERIAL NUMBER NOT PROVIDED IN JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. NO EVALUATION WAS PERFORMED AS THIS EVENT WAS REPORTED IN LITERATURE. DEVICE MANUFACTURING DATE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: DU J, GAO L, HUANG D, SHAN L, WANG W, FAN Y, HAO D, YAN L. RADIOLOGICAL AND CLINICAL DIFFERENCES BETWEEN TINAVI ORTHOPEDIC ROBOT AND O-ARM NAVIGATION SYSTEM IN THORACOLUMBAR SCREW IMPLANTATION FOR RECONSTRUCTION OF SPINAL STABILITY. MED SCI MONIT. 2020 SEP 12;26:E924770. DOI: 10.12659/MSM.924770. PMID: 32918810; PMCID: PMC7507796. SUMMARY: BACKGROUND: PEDICLE SCREW FIXATION IS ONE OF THE MOST COMMONLY USED METHODS IN SPINE SURGERY. WE INTRODUCE A SURGICAL ROBOT SYSTEM FROM CHINA BASED ON 3-DIMENSIONAL FLUOROSCOPY IMAGING AND COMPARE IT WITH THE COMMONLY USED O-ARM NAVIGATION SYSTEM. WE STUDY THE DIFFERENCES IN ACCURACY, SAFETY, AND CLINICAL EFFECT IN AUXILIARY PEDICLE SCREW FIXATION. MATERIAL/METHODS: PATIENTS WHO UNDERWENT THORACOLUMBAR INTERNAL FIXATION IN OUR HOSPITAL FROM 2017 TO 2019 WERE DIVIDED INTO A ROBOT AND NAVIGATION GROUP ACCORDING TO WHETHER SURGERY WAS ASSISTED BY THE TINAVI ORTHOPEDIC ROBOT OR O-ARM NAVIGATION SYSTEM. IMAGING DATA OF PATIENTS WERE SEARCHED FROM THE IMAGE SYSTEM AND ACCURACY OF SCREW IMPLANTATION WAS MEASURED BY RAMPERSAUD A TO D GRADE CLASSIFICATION. DEVIATION SAGITTAL, DEVIATION TRANSVERSAL, AND FACET JOINT VIOLATION WERE ALSO MEASURED AND CALCULATED. RESULTS: IN TOTAL, 306 PATIENTS WERE INCLUDED: 136 PATIENTS IN THE ROBOT GROUP WITH 760 SCREWS IMPLANTED; 166 PATIENTS IN THE NAVIGATION GROUP WITH 908 SCREWS IMPLANTED. THE ACCURACY OF ¿PERFECT¿ AND ¿CLINICALLY ACCEPTABLE¿ PEDICLE SCREW IMPLANTATION WAS 96.2% AND 99.6%, RESPECTIVELY, IN THE ROBOT GROUP AND 90.5% AND 96.7%, RESPECTIVELY, IN THE NAVIGATION GROUP, WITH A SIGNIFICANT DIFFERENCE BETWEEN THE 2 GROUPS (P<(><<)>0.05). THE SAGITTAL AND TRANSVERSAL DEVIATIONS IN THE ROBOT GROUP WERE SIGNIFICANTLY LESS THAN THOSE IN THE NAVIGATION GROUP (P<(> <<)>0.05). CONCLUSIONS: THE TINAVI ORTHOPEDIC ROBOT CAN SIGNIFICANTLY IMPROVE SURGICAL ACCURACY AND SAFETY OF PEDICLE SCREW FIXATION, AS COMPARED WITH THAT OF O-ARM NAVIGATION TECHNOLOGY, WITHOUT INCREASING COMPLICATIONS. IT SHOWS GREAT POTENTIAL IN CLINICAL APPLICATION. THE ACCURACY OF SCREW PLACEMENT WAS EVALUATED ACCORDING TO RAMPERSAUD A TO D CLASSIFICATION AS FOLLOWS: GRADE A, THE SCREW IS COMPLETELY WITHIN THE PEDICLE; GRADE B, THE SCREW PENETRATED THE PEDICLE¿S CORTEX <(><<)>2 MM; GRADE C, THE SCREW PENETRATED THE PEDICLE¿S CORTEX <(><<)>4 MM; AND GRADE D, THE SCREW PENETRATED THE PEDICLE¿S CORTEX 4 MM. GRADE A IS REGARDED AS ¿PERFECT¿ SCREW IMPLANTATION, GRADE A AND B ARE CONSIDERED AS ¿CLINICALLY ACCEPTABLE¿ SCREW PLACEMENT, AND GRADES C AND D ARE CONSIDERED ¿POOR¿ SCREW PLACEMENT POSITIONS (FIGURE 3). INTRAOPERATIVE SCREW REVISION DURING SURGERY WAS DIRECTLY RECOGNIZED AS GRADE D. REPORTED EVENTS: 1. 56 SCREWS WERE CONSIDERED GRADE B 2. 20 SCREWS WERE CONSIDERED GRADE C 3. 10 SCREWS WERE CONSIDERED GRADE D 4. MEAN SAGITTAL DEVIATION WAS 1.4 +/- 0.7 5. MEAN TRANSVERSAL DEVIATION WAS 1.6 +/- 0.8 SEE ATTACHED ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819603 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR