BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 19836237 · Received July 26, 2024

    Report

    Report Number
    1723170-2024-01810
    Event Type
    Injury
    Date Received
    July 26, 2024
    Date of Event
    June 30, 2015
    Report Date
    July 26, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. D4) DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. G4) 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. H4) DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. 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

    AKAZAWA, T., KOTANI, K., SAKUMA, T., MINAMI, S., TSUKAMOTO, S., ISHIGE, M. EVALUATION OF PEDICLE SCREW PLACEMENT BY PEDICLE CHANNEL GRADE IN ADOLESCENT IDIOPATHIC SCOLIOSIS: SHOULD WE CHALLENGE NARROW PEDICLES? J ORTHOP SCI (2015) 20:818¿822 DOI 10.1007/S00776-015-0746-0 BACKGROUND: SURGEONS OFTEN HAVE CONCERNS ABOUT WHETHER TO PLACE SCREWS IN NARROW PEDICLES FOR CORRECTION OF SCOLIOSIS. THE AIM OF THIS STUDY WAS TO USE PEDICLE CHANNEL GRADES BASED ON PREOPERATIVE CT TO EVALUATE PEDICLE SCREW PLACEMENT IN POSTERIOR SURGERY FOR ADOLESCENT IDIOPATHIC SCOLIOSIS. METHODS: THE SUBJECTS COMPRISED 55 PATIENTS WHO UNDERWENT POSTERIOR CORRECTION AND FUSION, AND A TOTAL OF 810 PEDICLES WERE EXAMINED IN WHICH SCREW PLACEMENT HAD BEEN PLANNED AND PROBING HAD BEEN PERFORMED. PEDICLE CHANNEL GRADES WERE DETERMINED BY MEASURING INNER PEDICLE DIAMETER ON PREOPERATIVE CT SCANS. THE GRADES WERE DEFINED AS GRADE 1 WITH AN INNER DIAMETER OF = 4 MM, GRADE 2 WITH AN INNER DIAMETER OF = 2 MM AND <(><<)> 4 MM, GRADE 3 WITH AN INNER DIAMETER OF = 1 MM AND <(> <<)> 2 MM, AND GRADE 4 FOR A ¿CORTICAL CHANNEL¿ WITH AN INNER DIAMETER OF <(><<)> 1 MM. RESULTS: THE FAILURE RATE OF SCREW PLACEMENT WAS 0.5 % FOR PEDICLE CHANNEL GRADE 1, 2.9 % FOR GRADE 2, 12.0 % FOR GRADE 3, AND 31.5 % FOR GRADE 4, SHOWING SIGNIFICANT DIFFERENCES (P <(><<)> 0.001). FOR THE LATERALITY OF CURVATURE, THE FAILURE RATE WAS 5.9 % FOR THE CONVEX SIDE, 8.0 % FOR THE NEUTRAL VERTEBRA, AND 9.0 % FOR THE CONCAVE SIDE, SHOWING NO SIGNIFICANT DIFFERENCE. THERE WAS ALSO NO SIGNIFICANT DIFFERENCE IN FAILURE RATE BETWEEN DEGREES OF CURVATURE OF <(><<)> 60° (8.2 %) AND = 60° (5.6 %). LOGISTIC ANALYSIS SHOWED THAT THE PEDICLE CHANNEL GRADE WAS A SIGNIFICANT RISK FACTOR FOR FAILURE (ODDS RATIO 4.0, P <(><<)> 0.001). CONCLUSIONS: THE FAILURE RATE OF SCREW PLACEMENT WAS 31.5 % FOR A CORTICAL CHANNEL WITH A PEDICLE INNER DIAMETER OF <(><<)> 1 MM. SCREW PLACEMENT SHOULD BE ATTEMPTED IN PEDICLES WITH AN INNER DIAMETER OF 1 MM OR LARGER. REPORTED EVENTS: STATUS WAS ¿CANCEL¿ IN 18 PEDICLES, PROBING HAD BEEN PERFORMED BUT SCREW PLACEMENT WAS DISCONTINUED DUE TO PERFORATION. STATUS ¿REMOVAL¿ IN 7 PEDICLES, SCREWS HAD BEEN REMOVED INTRAOPERATIVELY DUE TO MALPOSITION CONFIRMED BY IMAGING AFTER PLACEMENT. STATUS ¿DEVIATION¿ IN 36 PEDICLES, SCREWS HAD SHOWN A DEVIATION OF 2 MM OR MORE ON POSTOPERATIVE CT SCANS. A SURGERY-RELATED COMPLICATION OF INTRAOPERATIVE CEREBROSPINAL FLUID LEAKAGE WAS OBSERVED IN ONE GRADE 4 PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946321 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention