BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSS UNKNOWN

    MDR report key: 23494555 · Received November 7, 2025

    Report

    Report Number
    1625507-2025-02269
    Event Type
    Injury
    Date Received
    November 7, 2025
    Date of Event
    September 2, 2025
    Report Date
    November 7, 2025
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBE
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: NO CONCLUSION CAN BE DRAWN AS THE DEVICE WAS NO RETURNED FOR EVALUATION. 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

    IT WAS REPORTED IN INTERDISCIPLINARY NEUROSURGERY: ADVANCED TECHNIQUES AND CASE MANAGEMENT 41 (2025) 102122, ARTICLE NAME: ACCURACY AND SAFETY OF PEDICLE SCREWS INSERTED WITH IGS GUIDANCE THE IMPACT OF IGS REFERENCE ARRAY POSITION THAT A PILOT BURRHOLE WAS CREATED USING A MIDAS REX HIGH-SPEED DRILL. PEDICLE SCREW FIXATION WAS A COMMONLY USED METHOD FOR STABILIZING THE SPINE AND PROVIDING 3-COLUMN SUPPORT. THE EMERGENCE OF IMAGE-GUIDED SURGERY (IGS) HAS REVOLUTIONIZED SPINAL SURGERY, ALLOWING SURGEONS TO PERFORM PROCEDURES WITH GREATER ACCURACY AND SAFETY. ONE OF THE KEY COMPONENTS OF IGS SYSTEMS IS THE USE OF REFERENCE ARRAYS (RA) AND IMAGE-BASED NAVIGATION TO GUIDE SCREW PLACEMENT. THE AIM OF THIS STUDY WAS TO INVESTIGATE THE RELATIONSHIP BETWEEN PEDICLE SCREW PLACEMENT ACCURACY AND THE DISTANCE FROM THE IGS REFERENCE ARRAY. A TOTAL OF 93 PEDICLE SCREWS (18 CERVICAL, 49 THORACIC, AND 26 LUMBAR) WERE INSERTED IN 21 PATIENTS AT HOSPITAL BETWEEN OCTOBER 2017 AND JULY 2022. THE ACCURACY OF SCREW PLACEMENT WAS EVALUATED USING POST OPERATIVE CT SCANS. ONLY ONE PATIENT EXPERIENCED A COMPLICATION, WHICH WAS A CSF LEAK LIKELY DUE TO A DURAL TEAR DURING PEDICLE SCREW FIXATION THE CSF LEAK WAS LIKELY CAUSED BY DURAL INJURY BY THE PEDICLE SCREW, WHICH VIOLATED THE PEDICLE SCREW MEDIALLY. THE SMALL PEDICLES (4MM) COULD ALSO CONTRIBUTE TO THE PEDICLE VIOLATION IN THIS PARTICULAR CASE. CONCLUSION: THE RESULTS SUGGESTED THAT THE DISTANCE FROM THE REFERENCE ARRAY DID NOT SIGNIFICANTLY AFFECT SCREW ACCURACY WITHIN THE STUDIED RANGE (UP TO FOUR SEGMENTS). THEREFORE, FOR POSTERIOR SPINAL INSTRUMENTATION WITHIN FOUR SEGMENTS FROM THE REFERENCE ARRAY, RE-SCANNING AND RE-REGISTRATION MAY NOT BE NECESSARY, POTENTIALLY REDUCING OPERATIVE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180693 PSS UNKNOWN DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE HBE MDT POWERED SURGICAL SOLUTIONS PSS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other