BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 14946968 · Received July 7, 2022

    Report

    Report Number
    1723170-2022-01040
    Event Type
    Injury
    Date Received
    July 7, 2022
    Date of Event
    April 22, 2016
    Report Date
    July 7, 2022
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ENTRY. THIS VALUE REFLECTS THE MEAN AGE OF THE PATIENTS WHO UNDERWENT A LATERAL LUMBAR INTERBODY FUSION AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE MAJORITY GENDER OF THE PATIENTS WHO UNDERWENT A LATERAL LUMBAR INTERBODY FUSION AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THE ARTICLE DID NOT PROVIDE THE DATE OF THE PROCEDURE. THE EVENT DATE PROVIDED IS THE PUBLISHED ONLINE DATE. THE ARTICLE CITATION IS INCLUDED. THE SYSTEM PRODUCT NUMBER AND SERIAL NUMBER WERE NOT PROVIDED IN THE JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. NO 510K PROVIDED AS SYSTEM IS UNKNOWN. NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. DEVICE MANUFACTURING DATE IS UNAVAILABLE. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    JOSEPH, J. R., SMITH, B. W., PATEL, R. D., & PARK, P. (2016). USE OF 3D CT-BASED NAVIGATION IN MINIMALLY INVASIVE LATERAL LUMBAR INTERBODY FUSION. JOURNAL OF NEUROSURGERY: SPINE, 25(3), 339¿344. HTTPS://DOI.ORG/10.3171/2016.2.SPINE151295. OBJECTIVE: LATERAL LUMBAR INTERBODY FUSION (LLIF) IS AN INCREASINGLY POPULAR TECHNIQUE USED TO TREAT DEGENERATIVE LUMBAR DISEASE. THE TECHNIQUE OF USING AN INTRAOPERATIVE CONE-BEAM CT (ICBCT) AND AN IMAGE-GUIDED NAVIGATION SYSTEM (IGNS) FOR LLIF CAGE PLACEMENT HAS BEEN PREVIOUSLY DESCRIBED. HOWEVER, OTHER THAN A SMALL FEASIBILITY STUDY, THERE HAS BEEN NO CLINICAL STUDY EVALUATING ITS ACCURACY OR SAFETY. THEREFORE, THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE ACCURACY AND SAFETY OF IMAGE-GUIDED SPINAL NAVIGATION IN LLIF. METHODS: AN ANALYSIS OF A PROSPECTIVELY ACQUIRED DATABASE WAS PERFORMED. THIRTY-ONE CONSECUTIVE PATIENTS WERE IDENTIFIED. ACCURACY WAS INITIALLY DETERMINED BY COMPARISON OF THE PLANNED TRAJECTORY OF THE IGNS WITH POST¿CAGE PLACEMENT INTRAOPERATIVE FLUOROSCOPY. ACCURACY WAS SUBSEQUENTLY CONFIRMED BY POSTPROCEDURAL CT AND/OR RADIOGRAPHY. CAGE PLACEMENT WAS GRADED BASED ON A PREVIOUSLY DESCRIBED SYSTEM SEPARATING THE DISC SPACE INTO QUARTERS. RESULTS: THE MEAN PATIENT AGE WAS 63.9 YEARS. A TOTAL OF 66 SPINAL LEVELS WERE TREATED, WITH A MEAN OF 2.1 LEVELS (RANGE 1¿4) TREATED PER PATIENT. CAGE PLACEMENT WAS NOTED TO BE ACCURATE USING IGNS IN EACH CASE, AS CONFIRMED WITH INTRAOPERATIVE FLUOROSCOPY AND POSTOPERATIVE IMAGING. SIXTY-FOUR (97%) CAGES WERE PLACED WITHIN QUARTERS 1 TO 2 OR 2 TO 3, INDICATING PLACEMENT OF THE CAGE IN THE ANTERIOR OR MIDDLE PORTIONS OF THE DISC SPACE. THERE WERE NO INSTANCES OF MISGUIDANCE BY IGNS. THERE WAS 1 SIGNIFICANT APPROACH-RELATED COMPLICATION (PSOAS MUSCLE ABSCESS) THAT REQUIRED INTERVENTION, AND 8 PATIENTS WITH TRANSIENT, MILD THIGH PARESTHESIAS OR WEAKNESS. CONCLUSIONS: LLIF CAN BE SAFELY AND ACCURATELY PERFORMED UTILIZING ICBCT AND IGNS. ACCURACY IS ACCEPTABLE FOR MULTILEVEL PROCEDURES. REPORTED EVENT: THIRTY ONE PATIENTS WITH A HISTOLOGY OF DEGENERATIVE LUMBAR DISEASE UNDERWENT A LATERAL LUMBAR INTERBODY FUSION. ONE PATIENT DEVELOPED A PSOAS MUSCLE ABSCESS. TWO PATIENTS HAD A MYOCARDIAL INFARCTION, WITH ONE BEING A NON-ST-SEGMENT ELEVATION ASSOCIATED WITH ATRIAL FIBRILLATION AND RAPID VENTRICULAR RESPONSE. ONE PATIENT DEVELOPED THE MILLER-FISHER VARIANT OF ACUTE WITH INTERMITTENT DEMYELINATING POLYNEUROPATHY. ANOTHER PATIENT DEVELOPED URINARY RETENTION. ALL THE ABOVE PATIENTS MADE A FULL RECOVERY WITH NO RESIDUAL EFFECTS. ONE PATIENT'S PROCEDURE WAS ABORTED DUE TO AN ENDPLATE FRACTURE THAT OCCURRED DURING DISC PREPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1598463 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Other