BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 21079802 · Received January 6, 2025

    Report

    Report Number
    1723170-2025-00040
    Event Type
    Malfunction
    Date Received
    January 6, 2025
    Date of Event
    November 13, 2024
    Report Date
    January 6, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A5) PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ENTRY A2) THIS VALUE REFLECTS THE MEAN AGE OF THE PATIENTS WHO UNDERWENT TREATMENT FOR FIFTH LUMBAR SPONDYLOLYSIS AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. B3) THE ARTICLE DID NOT PROVIDE THE DATE OF THE PROCEDURE. THE EVENT DATE PROVIDED IS THE PUBLISHED DATE. B5) THE ARTICLE CITATION IS INCLUDED. D4) THE SYSTEM PRODUCT NUMBER AND SERIAL NUMBER WERE NOT PROVIDED IN THE JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. G3) NO 510K PROVIDED AS SYSTEM IS UNKNOWN. H3) NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. H4) DEVICE MANUFACTURING DATE IS 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

    CITATION: JI, Z., SHEN, M., SUN, J., WANG, J., DENG, Y., ZHANG, Y., WU, X., CHEN, K., <(>&<)> MAO, H. (2024). ENHANCED SAFETY AND EFFICACY OF O-ARM NAVIGATION OVER C-ARM GUIDANCE IN PERCUTANEOUS KYPHOPLASTY FOR PATIENTS WITH OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES AND SPINAL DEFORMITY: A COMPARATIVE STUDY. ORTHOPAEDIC SURGERY. HTTPS://DOI.ORG/10.1111/OS.14269 SUMMARY: BACKGROUND VARIOUS STRATEGIES, EACH WITH ITS OWN SET OF LIMITATIONS, ARE AVAILABLE FOR MANAGING LUMBAR SPONDYLOLYSIS. IN RESPONSE, OUR DEPARTMENT HAS DEVELOPED AN INNOVATIVE SOLUTION: A V-SHAPED TITANIUM CABLE INTEGRATED WITH A PEDICLE SCREW INTERNAL FIXATION SYSTEM SPECIFICALLY DESIGNED FOR LUMBAR SPONDYLOLYSIS IN YOUNG ADULTS. AIM THE OBJECTIVE OF THIS STUDY WAS TO THOROUGHLY INVESTIGATE THE LONG-TERM EFFICACY OF V-TYPE TITANIUM CABLE INTERNAL FIXATION FOR THE MANAGEMENT OF SPONDYLOLYSIS, ESPECIALLY IN YOUNG ADULTS. METHODS TWENTY-ONE PATIENTS WITH FIFTH LUMBAR SPONDYLOLYSIS WERE TREATED USING V-SHAPED TITANIUM CABLES AND PEDICLE SCREW INTERNAL FIXATION AT THE GENERAL HOSPITAL XINJIANG MILITARY COMMAND. THE DURATION OF LOW BACK PAIN BEFORE SURGERY WAS 6~48 (15.85±11.57) MONTHS. THE MEDTRONIC (S7) NAVIGATION SYSTEM WAS USED DURING SURGERY TO GUIDE THE PLACEMENT OF PEDICLE SCREWS, AIMING TO AVOID DAMAGING THE L4-5 FACET JOINT BY POSITIONING THE SCREWS LOWER AND FURTHER TO THE SIDE. INTRAOPERATIVE INDICES (OPERATIVE TIME AND INTRAOPERATIVE BLOOD LOSS) WERE RECORDED. THE VISUAL ANALOG SCALE (VAS), OSWESTRY DISABILITY INDEX (ODI), PELVIC INCIDENCE (PI), AND INTRAOPERATIVE IMAGING MEASUREMENTS OF SCREW ACCURACY WERE METICULOUSLY RECORDED AND ASSESSED IN A COMPREHENSIVE MANNER. THIS THOROUGH EVALUATION WAS CONDUCTED BOTH INTRAOPERATIVELY AND THROUGHOUT THE FOLLOW-UP PERIOD, WHICH LASTED FOR AT LEAST ONE YEAR. THE MACNAB EFFICACY CRITERIA WERE USED TO ASSESS POSTOPERATIVE OUTCOMES DURING THE FINAL FOLLOW-UP PERIOD. RESULTS ALL PATIENTS SUCCESSFULLY COMPLETED THE 1-YEAR FOLLOW-UP ON TIME. TWO PATIENTS EXPERIENCED POSTOPERATIVE WOUND LIQUEFACTION AND SUCCESSFULLY RECOVERED AFTER UNDERGOING DRESSING CHANGES. THE AVERAGE DURATION OF THE SURGICAL PROCEDURE WAS 113.09±6.97 MIN, AND AN INTRAOPERATIVE BLOOD LOSS OF 50.47±21.32 MILLILITRES WAS OBSERVED. SIGNIFICANT DIFFERENCES WERE NOTED IN VISUAL ANALOG SCALE (VAS) SCORES BEFORE AND AFTER SURGERY AT VARIOUS TIME INTERVALS, INDICATING IMPROVEMENT WITH THE PROGRESSION OF REHABILITATION EXERCISES. NO SIGNIFICANT CHANGES WERE FOUND IN THE PELVIC INCIDENCE (PI), AND THERE WERE NO NOTABLE DIFFERENCES BETWEEN THE PREOPERATIVE AND POSTOPERATIVE PERIODS. NO LOOSENING, BREAKAGE, OR FAILURE OF THE INTERNAL FIXATION WAS FOUND DURING THE LONG-TERM FOLLOW-UP. FURTHERMORE, THERE WERE NO SERIOUS COMPLICATIONS, SUCH AS INFECTION OR VASCULAR OR NERVE INJURIES. OCCURRED DURING THE PROCEDURE. A PATIENT WHO PRESENTED WITH A CONSIDERABLE CRYPTIC FISSURE OF SACRUM 1 EXPERIENCED DURAL INJURY DURING THE SURGICAL PROCEDURE. INTRAOPERATIVELY, DURAL SUTURES WERE SKILLFULLY APPLIED, AND THE ADJACENT MUSCLES WERE FORTIFIED. REMARKABLY, THE PATIENT ACHIEVED SUCCESSFUL HEALING IN A SINGLE STAGE. ON THE FIRST DAY POSTSURGERY, A GRADUAL IMPROVEMENT IN MOBILITY WAS NOTED. CONCLUSIONS THE USE OF A V-SHAPED TITANIUM CABLE IN CONJUNCTION WITH A PEDICLE SCREW INTERNAL FIXATION SYSTEM FOR THE MANAGEMENT OF FIFTH LUMBAR SPONDYLOLYSIS IN YOUNG INDIVIDUALS IS CHARACTERIZED BY ITS EASE OF EXECUTION AND ABILITY TO YIELD FAVORABLE OUTCOMES. THIS APPROACH RELIES ON THE PREREQUISITE THAT PATIENTS WITH MINIMAL INTERVERTEBRAL DISC INJURY OR MILD LUMBAR SPONDYLOLISTHESIS DEMONSTRATE HIGH OVERALL SUCCESS RATES BUT EXPERIENCE LOW FAILURE RATES ASSOCIATED WITH INTERNAL FIXATION. MOST SIGNIFICANTLY, THIS TECHNIQUE INVOLVES SEGMENTAL INTERNAL FIXATION, WHICH SAFEGUARDS THE FUNCTIONAL SPINAL UNIT (FSU). REPORTED EVENT: 1. TWENTY-ONE PATIENTS WITH FIFTH LUMBAR SPONDYLOLYSIS WERE TREATED USING V-SHAPED TITANIUM CABLES AND PEDICLE SCREW INTERNAL FIXATION. ACCORDING TO THE MACNAB CRITERIA, THE RESULTS WERE GOOD IN 3 PATIENTS, FAIR IN 1 PATIENT, AND POOR IN 1 PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962335 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Unknown