BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEVATE

    MDR report key: 22356297 · Received June 30, 2025

    Report

    Report Number
    1030489-2025-02349
    Event Type
    Injury
    Date Received
    June 30, 2025
    Date of Event
    May 6, 2025
    Report Date
    June 30, 2025
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MAX
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    JOSEPH JON YIN WAN, MRCS, JONATHAN YEO, MBBS, ZHIHONG CHEW, FRCSED (ORTHO), SHREE KUMAR DINESH, FRCS. COMPARATIVE COST-EFFECTIVENESS ANALYSIS BETWEEN NAVIGATED ROBOT-ASSISTED PLATFORMS AND O-ARM NAVIGATION IN MINIMALLY INVASIVE TRANSFORAMINAL INTERBODY FUSION (MIS-TLIF). ELSEVIER, THE SPINE JOURNAL, 2025, 1-6. HTTPS://DOI.ORG/10.1016/J.SPINEE.2025.05 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

    SUMMARY: MINIMAL INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) IS AN INCREASINGLY COMMON PROCEDURE USED IN TREATING DEGENERATIVE LUMBAR SPINE CONDITIONS. ADVANCEMENT OF ROBOT-ASSISTED TECHNOLOGY HAS IMPROVED ACCURACY OF INSTRUMENTATION WITH SMALLER INCISIONS, RESULTING IN BETTER SURGICAL OUTCOMES AND SHORTER HOSPITAL STAY. THIS STUDY AIMS TO ASSESS COST EFFECTIVENESS OF ROBOT-ASSISTED MINIMALLY INVASIVE TLIF (RA-TLIF);AND COMPARE PATIENT OUTCOMES WITH CONVENTIONAL O-ARM NAVIGATED MINIMALLY INVASIVE TLIF (ON-TLIF). METHOD: ATTACHMENT OF THE ROBOTIC ARM TO THE JACKSON TABLE AND ON THE PATIENT A SINGLE POSTERIOR SUPERIOR ILIAC SPINE (PSIS) SCHANZPIN. THISISFOL-LOWED BY ATTACHMENT OF THE REFERENCE ARRAY FIDUCIALS AND REGISTRATION OF THE SURGICAL FIELD FOLLOWED BY INTRAOPERATIVE 3-DIMENSIONAL FINE-CUT O-ARM SCAN (0.4-1MM; MAS:150KV/130MAS). PLANNING OF IMPLANT POSITION AND TRAJECTORY IS THEN PERFORMED ON THE WORKSTATION, AND THE ROBOTIC ARM MOVES IN TO POSITION TO ASSIST THE SURGEON IN EXECUTING THE INSTRUMENTATION. FINAL FLUOROSCOPIC CHECKS ARE THEN PERFORMED TO VERIFY THE IMPLANT POSITION, FOLLOWED BY LAYERED CLOSURE. POSTOPERATIVELY, ALL PATIENTS WERE ADMINISTERED EMPIRICAL INTRAVENOUS ANTIBIOTIC AND ORAL ANALGESIA AS PER HOSPITAL PROTOCOL. PRIOR TO DISCHARGE, PEDICLE SCREW PLACEMENT WAS QUALITATIVELY ASSESSED USING POST OPERATIVE X-RAYS. RESULT: IN THE ON-TLIF GROUP, 1 PATIENT HAD A DURAL TEAR IDENTIFIED WHICH WAS REPAIRED INTRAOPERATIVELY USING PROLENE 5-0 AND TACHO SIL COLLAGEN-BOUND FIBRIN SEALANT. 1 ON-TLIF PATIENT HAD PEDICLE SCREW LOOSENING, WHILE 2 OTHERS HAD MILD CAGE POSTERIOR MIGRATION, ALL OF WHOM WERE MANAGED NON SURGICALLY. 1 PATIENT HAD CAGE POSTERIOR MIGRATION CAUSING LOWER LIMB RADICULAR SYMPTOMS AND UNDERWENT SURGICAL REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929464 ELEVATE INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX WARSAW ORTHOPEDICS MSB_UNK_ELEVATE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention