BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 8655787 · Received May 30, 2019

    Report

    Report Number
    1723170-2019-02795
    Event Type
    Injury
    Date Received
    May 30, 2019
    Date of Event
    May 1, 2015
    Report Date
    May 30, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE OR DATE OF BIRTH: THE AVERAGE AGE OF THE 24 PATIENTS IS 62.2 YEARS. SEX: THERE WERE 3 MALE PATIENTS AND 21 FEMALE PATIENTS. WEIGHT: PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. DATE OF EVENT: EVENT DATE IS APPROXIMATED AS IT WAS REPORTED THAT THE SURGERIES OCCURRED BETWEEN MAY 2015 AND OCTOBER 2017. DESCRIPTION OF PROBLEM OR EVENT: THERE WAS NO ALLEGATION OF MALFUNCTION OF THE SYSTEM. LOT #, SERIAL #: DEVICE LOT NUMBER, OR SERIAL NUMBER AND MODEL NUMBER WERE UNAVAILABLE. UDI #: UDI NOT AVAILABLE FOR THIS SYSTEM AT TIME OF FILING. PMA/510K: THE PMA/ 510 (K) NUMBER IS UNAVAILABLE SINCE THE MODEL NUMBER IS UNKNOWN. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED, SO NO ANALYSIS WAS CONDUCTED. MANUFACTURE DATE: DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: WORLD NEUROSURG. (2019) 122: E1588-E1591. BACKGROUND: SIGNIFICANT PROGRESS IN HARDWARE AND SURGICAL TECHNIQUES FOR SACROILIAC JOINT (SIJ) FUSION SURGERIES HAS FACILITATED SAFER AND MORE EFFICACIOUS PROCEDURES FOR PATIENTS. TRIANGULAR-SHAPED IMPLANTS FOR SIJ FUSIONS ARE THE MOST-STUDIED DEVICES AND HAVE DEMONSTRATED GOOD SHORT-TERM AND LONG-TERM CLINICAL OUTCOMES. REPORTS ON CYLINDRICAL THREADED IMPLANTS ARE VERY LIMITED. OWING TO BIOMECHANICAL DIFFERENCES IN THE IMPLANTS AND THE SURGICAL TECHNIQUES REQUIRED FOR THEIR PLACEMENT, PREVIOUSLY REPORTED RESULTS MAY NOT BE APPLICABLE TO CYLINDRICAL THREADED IMPLANTS. THE AIM OF THIS STUDY WAS TO REPORT PRELIMINARY CLINICAL EXPERIENCE WITH MINIMALLY INVASIVE SIJ FUSION USING INTRAOPERATIVE STEREOTACTIC NAVIGATION AND THE RIALTO SI FUSION SYSTEM. METHODS: WE RETROSPECTIVELY REVIEWED 24 PATIENTS WHO UNDERWENT SIJ FUSIONS BETWEEN MAY 2015 AND OCTOBER 2017 PERFORMED BY A SINGLE SURGEON. RESULTS: MEAN TOTAL SATISFACTION SCORE WAS 89.0% 27.6%. A STATISTICALLY SIGNIFICANT REDUCTION (P [ 0.0028) IN LOW BACK PAIN SCORES WAS NOTED FROM AN AVERAGE BASELINE SCORE OF 6.6 2.4 TO 3.7 3.3 POSTOPERATIVELY. LEG PAIN SCORES DECREASED FROM 4.8 3.8 TO 1.5 2.9 (P [ 0.0034). MEAN SURGICAL TIME WAS 53.0 13.9 MINUTES. IT TOOK SIGNIFICANTLY LONGER (P [ 0.0089) TO PERFORM THE INITIAL 13 CASES (59.9 15.2 MINUTES) COMPARED WITH SUBSEQUENT CASES (45.4 7.3 MINUTES). ESTIMATED BLOOD LOSS WAS MINIMAL (10.4 5.2 ML). CONCLUSIONS: MINIMALLY INVASIVE SI JOINT FUSION USING CYLINDRICAL THREADED IMPLANTS CAN BE SAFELY PERFORMED WITH MINIMAL MORBIDITY AND GOOD CLINICAL OUTCOMES. ADVERSE EVENTS: 2 PATIENTS HAD SYMPTOMATIC SUBCUTANEOUS HEMATOMAS, WHICH RESOLVED SPONTANEOUSLY. 2 PATIENTS HAD SUPERFICIAL WOUND INFECTIONS TREATED WITH ANTIBIOTICS. ONE PATIENT DEVELOPED AN OSTEOPHYTE ON THE LATERAL ASPECT OF THE IMPLANT. BECAUSE OF SYMPTOMATIC PAIN LOCALIZED TO THAT AREA, AN OSTEOPHYTECTOMY WAS PERFORMED 1 YEAR AFTER THE INDEX SURGERY WITH AN IMPROVEMENT IN PATIENT SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449721 MEDTRONIC NAVIGATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other