BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 22108341 · Received May 29, 2025

    Report

    Report Number
    1723170-2025-02128
    Event Type
    Injury
    Date Received
    May 29, 2025
    Date of Event
    May 7, 2025
    Report Date
    May 29, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    YEH, C., HSIAO, P. H., CHEN, M. J., LO, Y. S., TSENG, C., LIN, C. Y., LI, L. Y., LAI, C. Y., CHANG, C. C., <(>&<)> CHEN, H. T. (2025). OUTCOME AND COMPLICATION FOLLOWING SINGLE-STAGED POSTERIOR MINIMALLY INVASIVE SURGERY IN ADULT SPINAL DEFORMITY. BMC MUSCULOSKELETAL DISORDERS, 26(1), 318. HTTPS://DOI.ORG/10.1186/S12891-025-08550-X ABSTRACT BACKGROUND THE AGING POPULATION IS EXPERIENCING A RISING INCIDENCE OF MUSCULOSKELETAL PROBLEMS AND DEGENERATIVE SPINAL DEFORMITIES. ADULT SPINAL DEFORMITY (ASD) PRESENTS CHALLENGES, WITH ASSOCIATED RISKS IN OPEN SURGERY. MINIMALLY INVASIVE SURGERY (MIS) IS BECOMING INCREASINGLY POPULAR DUE TO ITS POSITIVE OUTCOMES AND POTENTIAL BENEFITS. THIS STUDY AIMS TO EXPLORE THE CLINICAL OUTCOME AND COMPLICATIONS OF POSTERIOR APPROACH MIS IN PATIENTS WITH ASD. METHODS WE CONDUCTED A RETROSPECTIVE ANALYSIS OF PATIENTS WITH ADULT SPINAL DEFORMITY WHO UNDERWENT POSTERIOR MINIMALLY INVASIVE SURGERY. 46 PATIENTS MEETING THE CRITERIA WERE IDENTIFIED BETWEEN JUNE 2017 AND SEPTEMBER 2023. COMPREHENSIVE DATA WERE COLLECTED, INCLUDING DEMOGRAPHIC DETAILS, SURGICAL INFORMATION, FULL-LENGTH RADIOGRAPHIC MEASUREMENTS, AND VISUAL ANALOG SCALE (VAS) PAIN SCORES. THESE DATA WERE OBTAINED PREOPERATIVELY, POSTOPERATIVELY, AND AT THE FINAL FOLLOW-UP. RESULTS A TOTAL OF 46 PATIENTS WERE INCLUDED IN THE STUDY, WITH A MEAN AGE OF 68.58 YEARS AND A MINIMUM FOLLOW-UP PERIOD OF 6 MONTHS. THE MEAN OPERATIVE TIME WAS 327 MIN, AND THE MEAN BLOOD LOSS WAS 307 ML. PREOPERATIVE RADIOGRAPHIC MEASUREMENTS WERE AS FOLLOWS: CORONAL COBB ANGLE, 18.60± 11.35°; LUMBAR LORDOSIS (LL), 22.79 ± 21.87°; PELVIC INCIDENCE (PL), 53.05 ± 14.13°; PL-LL MISMATCH, 30.26 ± 23.48°; PELVIC TILT (PT), 32.53 ± 10.38°; TL PELVIC ANGLE (TPA), 31.91 ± 12.39°; AND SAGITTAL VERTICAL AXIS (SVA), 77.77 ± 60.47 MM. AT THE FINAL FOLLOW-UP, CORONAL COBB ANGLEVWAS 10.08±6.47° (P <(><<)>0.0001), LL WAS 26.16± 16.92° (P = 0.4293), PL WAS 54.17 ± 12.13° (P = 0.6965), PL-LL MISMATCH WAS 28.00± 17.03° (P = 0.6144), PT WAS 27.74± 10.24° (P = 0.0345), TPA WAS 25.10± 10.95 (P = 0.0090) AND SVA WAS 47.91 ±46.94 MM (P = O.QL 29). FUNCTIONAL OUTCOMES IMPROVED AS WELL, WITH THE MEAN OSWESTRY DISABILITY INDEX (ODI) DECREASING FROM 34.9 TO 23.6 AND THE VISUAL ANALOG SCALE (VAS) SCORE FOR BACK PAIN REDUCING FROM 8.4 TO 3.4. SURGICAL COMPLICATIONS OCCURRED IN 39.1 % OF CASES, WITH A LOW REOPERATION RATE OF 4.3%. CONCLUSION SINGLE-STAGED POSTERIOR MIS EFFECTIVELY CORRECTS GLOBAL ALIGNMENT IN ADULT SPINAL DEFORMITIES, SATISFYING PATIENT DEMAND AND YIELDING POSITIVE CLINICAL OUTCOME WITH LOW RE-OPERATION RATE. IN THIS STUDY, ONE PATIENT HAD COMPLICATIONS THAT WERE POTENTIALLY RELATED TO A MEDTRONIC DEVICE. A 55-YEAR-OLD MALE UNDERWENT NAVIGATION ASSISTED MIS-TLIF AT L2-3-4-5 FOR DECOMPRESSION AND CORRECTION DEVELOPED A RIGHT­ SIDE DROP FOOT AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625753 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Disability