BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 18818846 · Received March 1, 2024

    Report

    Report Number
    1723170-2024-00688
    Event Type
    Injury
    Date Received
    March 1, 2024
    Date of Event
    February 5, 2024
    Report Date
    April 16, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3) NO PARTS HAVE BEEN RETURNED FOR ANALYSIS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 0

    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

    RAJPAL S, BURNEIKIENE S. MINIMALLY INVASIVE SACROILIAC JOINT FUSION WITH CYLINDRICAL THREADED IMPLANTS USING INTRAOPERATIVE STEREOTACTIC NAVIGATION. WORLD NEUROSURG. 2019 FEB;122:E1588-E1591. DOI: 10.1016/J.WNEU.2018.11.116. EPUB 2018 NOV 23. PMID: 30476656. 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%. A STATISTICALLY SIGNIFICANT REDUCTION (P [ 0.0028) IN LOW BACK PAIN SCORES WAS NOTED FROM AN AVERAGE BASELINE SCORE OF 6.6 TO 3.7 POSTOPERATIVELY. LEG PAIN SCORES DECREASED FROM 4.8 TO 1.5 (P [ 0.0034). MEAN SURGICAL TIME WAS 53 MINUTES. IT TOOK SIGNIFICANTLY LONGER (P [ 0.0089) TO PERFORM THE INITIAL 13 CASES COMPARED WITH SUBSEQUENT CASES (45.4). ESTIMATED BLOOD LOSS WAS MINIMAL (10.4). CONCLUSIONS: MINIMALLY INVASIVE SI JOINT FUSION USING CYLINDRICAL THREADED IMPLANTS CAN BE SAFELY PERFORMED WITH MINIMAL MORBIDITY AND GOOD CLINICAL OUTCOMES. EVENTS: 2 PATIENTS HAD SYMPTOMATIC SUBCUTANEOUS HEMATOMAS THAT 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. TWO PATIENTS HAD QUESTIONABLE PERIPROSTHETIC LUCENCIES SEEN ON PELVIC X-RAYS, BUT NO FURTHER IMAGING WAS PURSUED BECAUSE BOTH PATIENTS WERE ASYMPTOMATIC AND THE DECISION WAS MADE TO FOLLOW THEM CLINICALLY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS REPORTED. IT WAS REPORTED THAT NONE OF THE ADVERSE EFFECTS WERE DUE TO THE HARDWARE THEMSELVES. NO DEVICES WERE REMOVED SO NO RETURN WAS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919926 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention