BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 21761466 · Received April 3, 2025

    Report

    Report Number
    1723170-2025-01542
    Event Type
    Injury
    Date Received
    April 3, 2025
    Date of Event
    November 13, 2024
    Report Date
    April 3, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 ACCEPTED 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

    DE BIASE. G., GRUENBAUM, B.F., BOJAXHI, E., PATTERSON, J.S., SABETTA, K., QUINONES-HINOJOSA, A., ABODE-IYAMAH, K. AWAKE MINIMALLY INVASIVE SURGERY TRANSFORAMINAL LUMBAR INTERBODY FUSION UNDER SPINAL ANESTHESIA: SCREW PLACEMENT ACCURACY AND 1 YEAR FOLLOW-UP. 2025. 195(123478). HTTPS://DOI.ORG/10.1016/J.WNEU.2024.11.061. OBJECTIVE WE ASSESSED THE ACCURACY OF PEDICLE SCREWS PLACED DURING AWAKE MINIMALLY INVASIVE SURGERY (MIS) TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) UNDER SPINAL ANESTHESIA AND ANALYZED OUTCOMES AT THE 1-YEAR FOLLOW-UP. METHODS WE INCLUDED PATIENTS WHO UNDERWENT AWAKE MIS-TLIF UNDER SPINAL ANESTHESIA AT AN ACADEMIC CENTER FROM FEBRUARY 2020 TO FEBRUARY 2022. THE GERTZBEIN-ROBBINS CLASSIFICATION WAS USED FOR SCREW ACCURACY RATING. RESULTS A TOTAL OF 100 PEDICLE SCREWS WERE INSERTED IN 24 PATIENTS, WITH THE MOST COMMON LEVEL BEING L4-5. MEDIAN AGE WAS 63.5 ± 16.5 (INTERQUARTILE RANGE) YEARS, 42% MALE, MEDIAN BODY MASS INDEX 28 ± 6 KG/M2, AND MEDIAN AMERICAN SOCIETY OF ANESTHESIOLOGISTS CLASS WAS 2 ± 1. TWO PATIENTS UNDERWENT A 2-LEVEL FUSION, AND 22 PATIENTS UNDERWENT A 1-LEVEL FUSION. MEDIAN ESTIMATED BLOOD LOSS WAS 35 ± 25 ML, MEDIAN LENGTH OF STAY WAS 0 ± 1 DAY, WITH 54% OF PATIENTS GOING HOME ON THE DAY OF SURGERY, AND THE ONLY INTRAOPERATIVE COMPLICATION WAS 1 DUROTOMY. MEDIAN PROCEDURE TIME WAS 112 ± 23.5 MINUTES, AND MEDIAN OPERATING ROOM TIME (INCLUDING THE SPINAL BLOCK) WAS 159.5 ± 32.7 MINUTES; 67% OF THE SCREWS WERE PLACED WITH NAVIGATION, AND 33% WERE ROBOTIC-ASSISTED (MAZOR X); 99% OF THE SCREWS WERE GERTZBEIN ROBINS GRADE A, AND 1% GRADE E. AT THE 1 YEAR FOLLOW-UP, COMPUTED TOMOGRAPHY SHOWED NO EVIDENCE OF PSEUDARTHROSIS, AND ALL PATIENTS REPORTED IMPROVEMENT IN THEIR PRESENTING SYMPTOMS. CONCLUSIONS OUR STUDY SHOWS A HIGH ACCURACY (99%) OF PEDICLE SCREW PLACEMENT IN PATIENTS UNDERGOING AWAKE MIS-TLIF UNDER SPINAL ANESTHESIA AND S IGNIFICANT IMPROVEMENT OF THEIR SYMPTOMS AT 1-YEAR FOLLOW-UP. REPORTED EVENTS: ONE PATIENT WITH A GRADE E, =6-MM PEDICLE BREACH. THE INCIDENCE OF INTRAOPERATIVE COMPLICATIONS WAS MINIMAL, WITH A SINGULAR CASE OF DUROTOMY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1957232 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention