BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 23209914 · Received October 3, 2025

    Report

    Report Number
    1723170-2025-03381
    Event Type
    Injury
    Date Received
    October 3, 2025
    Date of Event
    August 4, 2025
    Report Date
    October 3, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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 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

    GUNERBUYUK, C., AKGUN, M. Y., DURMUS, N., UCAR, E. A., ORAK, H. I., OKTENOGLU, T., ATES, O., AKGUL, T., OZER, A. F. DYNAMIC VS. RIGID: TRANSFORMING THE TREATMENT LANDSCAPE FOR MULTISEGMENTAL LUMBAR DEGENERATION. JOURNAL OF CLINICAL MEDICINE. 2025 14(15), 5472. HTT PS://DOI.ORG/10.3390/JCM14155472 BACKGROUND: MULTISEGMENTAL LUMBAR DEGENERATIVE DISEASE (MS-LDD) IS A COMMON CONDITION IN OLDER ADULTS, OFTEN REQUIRING SURGICAL INTERVENTION. WHILE RIGID STABILIZATION REMAINS THE GOLD STANDARD, IT IS ASSOCIATED WITH COMPLICATIONS SUCH AS ADJACENT SEGMENT DISEASE (ASD), HIGHER BLOOD LOSS, AND LONGER RECOVERY TIMES. THE DYNESYS DYNAMIC STABILIZATION SYSTEM OFFERS AN ALTERNATIVE BY PRESERVING MOTION WHILE STABILIZING THE SPINE. HOWEVER, DATA COMPARING DYNESYS WITH FUSION IN MULTISEGMENTAL CASES ARE LIMITED. OBJECTIVE: THIS STUDY EVALUATES THE CLINICAL AND RADIOGRAPHIC OUTCOMES OF DYNESYS DYNAMIC STABILIZATION VERSUS RIGID STABILIZATION IN THE TREATMENT OF MS-LDD. METHODS: A RETROSPECTIVE ANALYSIS WAS CONDUCTED ON 53 PATIENTS (MEAN AGE: 62.25 ± 15.37 YEARS) WHO UNDERWENT EITHER DYNESYS DYNAMIC STABILIZATION (N = 27) OR PLIF (N = 26) FOR MS-LDD INVOLVING AT LEAST SEVEN MOTION SEGMENTS. CLINICAL OUTCOMES WERE ASSESSED USING THE VISUAL ANALOG SCALE (VAS) AND OSWESTRY DISABILITY INDEX (ODI), WHILE RADIOLOGICAL PARAMETERS SUCH AS LUMBAR LORDOSIS (LL), SAGITTAL VERTICAL AXIS (SVA), AND SPINOPELVIC PARAMETERS (PELVIC INCIDENCE, PELVIC TILT AND, SACRAL SLOPE) WERE ANALYZED. A TWO-STAGE SURGICAL APPROACH WAS EMPLOYED IN THE DYNESYS GROUP TO ENHANCE OSSEOINTEGRATION, PARTICULARLY IN ELDERLY OSTEOPOROTIC PATIENTS. RESULTS: BOTH GROUPS SHOWED SIGNIFICANT IMPROVEMENTS IN VAS AND ODI SCORES POSTOPERATIVELY (P 0.001), WITH NO SIGNIFICANT DI FFERENCES BETWEEN THEM. HOWEVER, THE DYNESYS GROUP DEMONSTRATED SUPERIOR SAGITTAL ALIGNMENT CORRECTION, WITH A SIGNIFICANT INCREASE IN LL (P 0.002) AND A SIGNIFICANT DECREASE IN SVA (P 0.0015), WHEREAS CHANGES IN THE RIGID STABILIZATION GROUP WERE NOT STATISTICALLY SIGNIFICANT. ADDITIONALLY, THE DYNESYS GROUP HAD FEWER COMPLICATIONS, INCLUDING A LOWER INCIDENCE OF ASD (0 VS. 6 CASES). THE TWO-STAGE TECHNIQUE FACILITATED IMPROVED SCREW OSSEOINTEGRATION AND REDUCED SURGICAL RISKS INOSTEOPOROTIC PATIENTS. CONCLUSIONS: DYNESYS DYNAMIC STABILIZATION IS AN EFFECTIVE ALTERNATIVE TO RIGID STABILIZATION IN MS-LDD, OFFERING COMPARABLE PAIN RELIEF AND FUNCTIONAL IMPROVEMENT WHILE PRESERVING MOTION AND REDUCING ASD RISK. THE TWO-STAGE APPROACH ENHANCES LONG-TERM STABILITY, MAKING IT PARTICULARLY SUITABLE FOR ELDERLY OR OSTEOPOROTIC PATIENTS. FURTHER LONG-TERM STUDIES ARE NEEDED TO CONFIRM THESE FINDINGS. REPORTED EVENTS: DYNESYS GROUP: THREAD BREAKAGE OCCURRED IN 2/27 PATIENTS ALL CASES IN BOTH DYNAMIC AND RIGID STABILIZATION GROUPS REQUIRED REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2434655 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention