BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 19728851 · Received July 12, 2024

    Report

    Report Number
    1723170-2024-01672
    Event Type
    Injury
    Date Received
    July 12, 2024
    Date of Event
    June 9, 2023
    Report Date
    July 12, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. A3) PATIENT GENDER IS THE MAJORITY VALUE OF PATIENT IN THE STUDY. A4) PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. B3) EVENT DATE IS THE ONLINE ACCEPTED 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. H3,H6) 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

    LI, W., TONG, G., CAI, B., QUAN, R. ANALYSIS OF THE OUTCOME OF BI-VERTEBRAL TRANSPEDICULAR WEDGE OSTEOTOMY FOR CORRECTING SEVERE KYP HOTIC DEFORMITY IN ANKYLOSING SPONDYLITIS. MEDICINE 2023;102:26(E34155). HTTP://DX.DOI.ORG/10.1097/MD.0000000000034155 TO STUDY THE OUTCOMES OF BI-VERTEBRAL TRANSPEDICULAR WEDGE OSTEOTOMY IN CORRECTING SEVERE KYPHOTIC DEFORMITY IN ANKYLOSING SPONDYLITIS (AS).THIS RETROSPECTIVE STUDY FOCUSED ON ALL THE PATIENTS WHO UNDERWENT THORACIC AND LUMBAR BI-VERTEBRA TRANSPEDICULAR WEDGE OSTEOTOMY WITH PEDICLE SCREW INTERNAL FIXATION TO TREAT THEIR SEVERE THORACOLUMBAR KYPHOTIC DEFORMITY OF AS IN OUR HOSPITAL FROM JANUARY 2014 TO JANUARY 2020. THE PERIOPERATIVE AND OPERATIVE DATA OF EACH PATIENT WERE COLLECTED AND ANALYZED. A TOTAL OF 21 MALE AS PATIENTS WITH SEVERE KYPHOTIC DEFORMITY WERE STUDIED WITH A MEAN AGE OF 42.2 ± 9.2 YEARS. INTRAOPERATIVELY, THE MEAN OPERATING TIME IS 5.8 ± 1.6 HOUR WITH A MEAN BLOOD LOSS OF 725.5 ± 140.6ML. THE AVERAGE POSTOPERATIVE CORRECTION OF KYPHOSIS REACHED 60.8O AT 1 WEEK AFTER THE SURGERY, WHICH IS SIGNIFICANTLY IMPROVED FROM PREOPERATIVE PRESENTATION (P <(><<)> .05), AND STAYED NO SIGNIFICANT CHANGE OVER THE TIME DURING LONGER PERIOD OF FOLLOW-UPS (12¿24 MONTHS) WITH THE OVERALL CORRECTION RATE OF 72.2%. MOREOVER, THE POSTOPERATIVE CHANGES IN THORACIC KYPHOSIS (TK) ANGLE, THORACOLUMBAR KYPHOSIS (TLK) ANGLE, LUMBAR LORDOSIS (LL) ANGLE, MAXILLA-BROW ANGLE, AS WELL AS C2SVA AND C7SVA SAGITTAL BALANCE WERE ALSO SIGNIFICANT, ALL OF WHICH ENABLED THE PATIENTS TO WALK IN UPRIGHT POSITION AND SLEEP IN THE SUPINEPOSITION WITH THE IMPROVEMENTS IN OTHER CLINICAL SYMPTOMS. BI-VERTEBRAL TRANSPEDICULAR WEDGE OSTEOTOMY OF THORACIC AND LUMBAR VERTEBRAE IS A SAFE AND EFFECTIVE METHOD TO RESTORE THE PHYSIOLOGICAL CURVATURE OF THE SAGITTAL POSITION OF THE SPINE AND CORRECT SEVERE ANKYLOSING DEFORMITY. REPORTED EVENTS: 1 PATIENT WAS FOUND TO HAVE A SMALL DURAL RUPTURE, WHICH HAD BEEN REPAIRED BY CUTTING THE APPROPRIATE SIZE MYOFASCIA IN THE WOUND 1 PATIENT DEVELOPED PAIN IN 1 LOWER LIMB AND WEAKENING IN MUSCLE STRENGTH TO GRADE 4 ON THE SECOND POSTOPERATIVE DAY, WHICH EXPERIENCED A FULL RECOVERY 2 MONTHS AFTER DEHYDRATION AND NEUROTROPHIC TREATMENT 2 PATIENTS DEVELOPED SUPERFICIAL WOUND INFECTION 1 WEEK AFTER SURGERY, WHICH WAS HEALED BY THE PROCEDURES OF DEBRIDEMENT AND SUTURE FOR THE PATIENT WITH C7 OSTEOTOMY, HE DEVELOPED NUMBNESS ALONG THE MEDIAL SIDE OF 1 FOREARM AND LITTLE FINGER, WHICH RECOVERED 2 WEEKS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272245 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention