BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSS UNKNOWN TOOL

    MDR report key: 21880129 · Received April 22, 2025

    Report

    Report Number
    1625507-2025-01487
    Event Type
    Malfunction
    Date Received
    April 22, 2025
    Date of Event
    February 20, 2025
    Report Date
    April 22, 2025
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBE
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: NO CONCLUSION CAN BE DRAWN AS THE DEVICE WAS NOT RETURNED. 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 JOURNAL OF SPRINGER NATURE IN INTERNATIONAL ORTHOPAEDICS SURGICAL, ARTICLE NAME: SAFETY AND EFFICACY OF ULTRASONIC BONE SCALPEL COMPARED WITH A HIGH SPEED DRILL IN SPINAL SURGERY: OUR EXPERIENCE IN SIXTY CASES THAT AIMED TO EVALUATE THE EFFECTIVENESS AND SAFETY OF UBS (ULTRASONIC BONE SCALPEL) AND HSD (HIGH PURPOSE SPEED DRILL) FOR PERFORMING ANTERIOR OR POSTERIOR DECOMPRESSIONS IN PATIENTS WITH PATHOLOGIES IN CERVICAL AND LUMBAR REGIONS. RESULTS THAT IN UBS GROUP, THE MEAN INTRAOPERATIVE BLOOD LOSS WAS 166.0 ± 64.3 ML. THE MEAN PREOPERATIVE AND POSTOPERATIVE JOA SCORES WERE 4.5 ± 1.0 AND 8.6 ± 1.8 AND THE MEAN POSTOPERATIVE FOLLOW-UP DURATION WAS 6.1 ± 4.4 MONTHS IN UBS GROUP. THE MEAN INTRAOPERATIVE BLOOD LOSS WAS 221.2 ± 93.4 ML IN HSD GROUP. THE MEAN PREOPERATIVE AND POSTOPERATIVE JOA SCORES WERE 5.2 ± 1.1 AND 8.2 ± 1.2 IN HSD GROUP. IN THE HSD GROUP, THE BLOOD LOSS (BL) VALUE WAS SIGNIFICANTLY HIGHER (P 0.05) COMPARED TO THE UBS GROUP. THE PREOPERATIVE/POSTOPERATIVE JOA SCORE IMPROVEMENT IN THE UBS GROUP WAS SIGNIFICANTLY HIGHER (P 0.05) THAN IN THE HSD GROUP. BETWEEN OCTOBER 2022 AND JUNE 2024, 60 PATIENTS UNDERWENT SURGERY IN WHICH A UBS (SONOPET UST-2001; STRYKER NEURO SPINE ENT, MI, USA) AND HIGH-SPEED MIDAS REX MR8 (MEDTRONIC, FORT WORTH, TX, USA) DRILL WAS USED. IN STUDY, NO COMPLICATIONS SUCH AS POSTOPERATIVE HAEMATOMA, DURAL TEAR, OR THERMAL DAMAGE DUE TO THE USE OF UBS WERE OBSERVED. IN ONE PATIENT WITH L4-5 SPINAL STENOSIS AND RIGHT L4-5 DISC HERNIATION, DUE TO THE SEVERE BACK AND RIGHT LEG PAIN IN THE POSTOPERATIVE PERIOD, A CONTRAST-ENHANCED LUMBAR MRI WAS PERFORMED, AND REVEALED SPONDYLODISCITIS. THE PATIENT UNDERWENT REOPERATION FOR EXPLORATION, AND A SAMPLE WAS TAKEN FROM THE INFECTED TISSUE. IN SUBSEQUENT FOLLOW-UPS, SINCE THE PATIENT¿S BACK AND RIGHT LEG PAIN PERSISTED, THE L4-5 DECOMPRESSION WAS EXTENDED AND L3-S1 POSTERIOR STABILIZATION WAS PERFORMED. THE PATIENT, WHO RECEIVED ANTIBIOTIC TREATMENT FOR SIX WEEKS, WAS DISCHARGED AFTER THE SYMPTOMS SUBSIDED. IN THE HSD GROUP, DURAL TEAR WAS OBSERVED IN TWO PATIENTS, AND PRIMARY DURA REPAIR WAS PERFORMED PEROPERATIVELY. NO CSF FISTULAS DEVELOPED DURING FOLLOW-UP, AND THE PATIENTS WERE DISCHARGED UNEVENTFULLY. IN THE UBS GROUP, NO PATIENTS EXPERIENCED INTRAOPERATIVE DURAMATER INJURY. CONCLUDES THAT THE UBS CAN BE SAFELY USED IN SPINAL SURGERY. IT REDUCES INTRAOPERATIVE BLOOD LOSS AND PROVIDE BETTER CLINICAL IMPROVEMENT. AUTHORS WOULD LIKE TO EMPHASIZE THAT THE UBS RESECTS THE BONE WITH OSCILLATORY MOVEMENTS RATHER THAN ROLLING MOTIONS AND THIS MECHANISM OF ACTION IS IMPORTANT IN REDUCING THE RISK OF DURA MATER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1352496 PSS UNKNOWN TOOL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE HBE MDT POWERED SURGICAL SOLUTIONS PSS UNKNOWN TOOL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female