BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATALANTE X

    MDR report key: 19874032 · Received July 31, 2024

    Report

    Report Number
    3015000676-2024-70001
    Event Type
    Injury
    Date Received
    July 31, 2024
    Date of Event
    June 27, 2024
    Report Date
    July 30, 2024
    Manufacturer
    WANDERCRAFT
    Product Code
    PHL
    PMA / PMN Number
    K232077
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ADVERSE EVENT WAS REPORTED TO WANDERCRAFT ON (B)(6) 2024, WITH A PLANNED REPORTING DATE TO THE FDA OF JULY 30, 2024. HOWEVER, WANDERCRAFT IS CURRENTLY STILL IN THE ENROLLMENT PROCESS FOR ELECTRONIC SUBMISSION. THE SUBMISSION WILL BE COMPLETED PROMPTLY ONCE WANDERCRAFT RECEIVES ITS PRODUCTION ACCOUNT FROM ESG. ANY POTENTIAL DELAY BEYOND THE 30-DAY TIMELINE IS DUE TO THESE TECHNICAL ISSUES (SEE EMAILS TO ESG AND EMDR ON JULY 30TH).

    Description of Event or Problem · 0

    DURING A SESSION WITH THE ATALANTE X EXOSKELETON IN FRANCE, A PATIENT WHO HAD PREVIOUSLY COMPLETED SEVERAL SESSIONS EXPERIENCED A DROP IN BLOOD PRESSURE AND FELT UNWELL AFTER 15 MINUTES OF WALKING. THE PATIENT WAS IMMEDIATELY SEATED AND EXTRACTED FROM THE EXOSKELETON FOLLOWING THE DEVICE'S EMERGENCY EXTRACTION PROCEDURE. AFTER ASSESSING THE PATIENT'S CONDITION AND CONFIRMING IT HAD RETURNED TO NORMAL, THE SESSION WAS HALTED, AND THE PATIENT WAS SENT HOME. THE NEXT DAY, THE PATIENT CONTACTED HER PHYSICIAN AFTER NOTICING PAIN, SWELLING AND SIGNIFICANT BRUISING ON THE LATERAL PART OF HER FOOT AND ANKLE. THE PHYSICIAN PRESCRIBED AN X-RAY AND A CT SCAN, WHICH REVEALED TWO FRACTURES: A TRANSVERSE FRACTURE AT THE DISTAL END OF THE TIBIA (AT THE JUNCTION BETWEEN THE METAPHYSIS AND THE EPIPHYSIS) WITHOUT DISPLACEMENT, AND A NON-DISPLACED INTERTUBEROSITY FRACTURE OF THE FIBULAR MALLEOLUS. THE PATIENT RECEIVED ORTHOPEDIC TREATMENT WITH AN OFFLOADING WALKING BOOT. POST-INCIDENT MEDICAL EXAMINATION RESULTS: AN ECHODOPPLER EXAMINATION DID NOT REVEAL SIGNS OF DEEP VENOUS THROMBOSIS. BONE DENSITOMETRY RESULTS INDICATED SEVERE OSTEOPOROSIS IN THE LUMBAR VERTEBRAE AND FEMORAL HEAD. BLOOD TESTS SHOWED ELEVATED C-REACTIVE PROTEIN (CRP) LEVELS, POSSIBLY INDICATING INFLAMMATION, ALONG WITH VITAMIN D DEFICIENCY AND DECREASED TOTAL SERUM PROTEIN CONCENTRATION. THE ACCOMPANYING PHYSIOTHERAPISTS REPORTED THAT THE EXOSKELETON WAS CORRECTLY ADJUSTED TO THE PATIENT'S SIZE AND THAT THE PATIENT WAS PROPERLY DONNED. THE SESSION HAD STARTED WITHOUT ANY ISSUE. IT IS SUSPECTED THAT DURING THE EMERGENCY EXTRACTION, THE PATIENT'S FOOT MAY HAVE BEEN BRIEFLY TRAPPED, CAUSING THE FRACTURES. HOWEVER, THE EXACT DYNAMICS IS UNCERTAIN AS THE PATIENT DID NOT REPORT ANY PAIN AT THAT TIME, AND THE EXTRACTION PROCESS DETAILS ARE UNCLEAR. ADDITIONALLY, IT WAS FOUND AFTERWARDS THAT THE PATIENT HAD SEVERE OSTEOPOROSIS WHICH IS A CONTRAINDICATION FOR USING THE ATALANTE X EXOSKELETON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216851 ATALANTE X EXOSKELETON PHL WANDERCRAFT DMR-ATA-002.3

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention