BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 20063063 · Received August 26, 2024

    Report

    Report Number
    1723170-2024-02347
    Event Type
    Injury
    Date Received
    August 26, 2024
    Date of Event
    July 9, 2024
    Report Date
    October 2, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN SECTION B5 AND D4. 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.

    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

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ADVERSE EVENTS MENTIONED IN THE ARTICLE ARE NOT RELATED TO MEDTRONIC DEVICES.

    Description of Event or Problem · 0

    LIN, X., CHANG, Q., SHANG, L., SHEN, S., FU, Z., ZHAO, G. A COMPARISON OF ULTRASOUND VOLUME NAVIGATION, O-ARM NAVIGATION, AND X-RAY GUIDANCE FOR SCREW PLACEMENT IN MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION: A RANDOMIZED CONTROLLED TRIAL. EUROPEAN SPINE JOURNAL. 2024. HTTPS://DOI.ORG/10.1007/S00586-024-08390-8 OBJECTIVE: TO COMPARE THE DIFFERENCES BETWEEN ULTRASOUND VOLUME NAVIGATION (UVN), O-ARM NAVIGATION, AND CONVENTIONAL X-RAY FLUOROSCO PY-GUIDED SCREW PLACEMENT IN MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS-TLIF) SURGERIES. METHODS: A TOTAL OF 90 PATIENTS WHO UNDERWENT MIS-TLIF DUE TO LUMBAR DISC HERNIATION FROM JANUARY 2022 TO JANUARY 2023 WERE RANDOMLY ASSIGNED TO THE UVN GROUP, O-ARM GROUP, AND X-RAY GROUP. UVN, O-ARM NAVIGATION, AND X-RAY GUIDANCE WERE USED FOR SCREW PLACEMENT IN THE RESPECTIVE GROUPS, WHILE THE REMAINING SURGICAL PROCEDURES FOLLOWED ROUTINE MIS-TLIF PROTOCOLS. INTRAOPERATIVE DATA INCLUDING AVERAGE SINGLE SCREW PLACEMENT TIME, TOTAL RADIATION DOSE, AND AVERAGE EFFECTIVE RADIATION DOSE PER SCREW WERE RECORDED AND CALCULATED. ON THE 10TH DAY AFTER SURGERY, POSTOPERATIVE X-RAY AND CT EXAMINATIONS WERE CONDUCTED TO ASSESS SCREW PLACEMENT ACCURACY AND FACET JOINT VIOLATION. RESULTS: THERE WERE NO SIGNIFICANT DIFFERENCES IN GENERAL CHARACTERISTICS AMONG THE THREE GROUPS, ENSURING COMPARABILITY. FIRSTLY, THE AVERAGE SINGLE SCREW PLACEMENT TIME IN THE O-ARM GROUP WAS SIGNIFICANTLY SHORTER THAN THAT IN THE UVN GROUP AND X-RAY GROUP (P0.0 5), WHILE THE UVN GROUP WAS SIGNIFICANTLY LOWER THAN THE OTHER TWO GROUPS (P0.05). HOWEVER, IN TERMS OF FACET JOINT VIOLATION RATE, THE UVN GROUP (10.3%) AND O-ARM GROUP (10.7%) SHOWED NO SIGNIFICANT DIFFERENCE (P>0.05), WHILE THE X-RAY GROUP (26.7%) WAS SIGNIFICANTLY HIGHER THAN BOTH GROUPS (P<(><<)>0.05). MOREOVER, IN THE UVN GROUP, THERE WERE SIGNIFICANT CORRELATIONS BETWEEN AVERAGE SINGLE SCREW PLACEMENT TIME AND PLACEMENT GRADE WITH BMI INDEX (R=0.637, P<(> <<)>0.05; R=0.504, P<(><<)>0.05), WHILE NO SIMILAR SIGNIFICANT CORRELATIONS WERE FOUND IN THE O-ARM AND X-RAY GROUPS. CONCLUSION: UVN-GUIDED SCREW PLACEMENT IN MIS-TLIF SURGERIES DEMONSTRATES COMPARABLE EFFICIENCY, VISUALIZATION, AND ACCURACY TO O-ARM NAVIGATION, WHILE SIGNIFICANTLY REDUCING RADIATION EXPOSURE COMPARED TO BOTH O-ARM NAVIGATION AND X-RAY GUIDANCE. HOWEVER, UVN MAY BE INFLUENCED BY FACTORS LIKE OBESITY, LIMITING ITS APPLICATION. REPORTED EVENTS: 48 SCREWS WITH GRADE 1 (36.9%) 5 SCREWS WITH GRADE 2 (3.8%) ALL SCREWS THAT PENETRATED THE PEDICLE BROKE THROUGH THE LATERAL WALL OF THE PEDICLE, WITHOUT ANY OCCURRENCE OF SPINAL CANAL VIOLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160093 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735667

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention