BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REWALK PERSONAL P6.0

    MDR report key: 20220329 · Received September 15, 2024

    Report

    Report Number
    3007615665-2024-00001
    Event Type
    Injury
    Date Received
    September 15, 2024
    Date of Event
    August 20, 2024
    Report Date
    July 24, 2025
    Manufacturer
    LIFEWARD LTD.
    Product Code
    PHL
    PMA / PMN Number
    K221696
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FINAL REPORT AND INVESTIGATION MAIN FINDINGS: DATE: JULY 28 2025 THE INVESTIGATION ACTIVITIES INCLUDED THE FOLLOWING: ·REVIEWING DEVICE RECORDS. ·INTERVIEWING THE CLINICAL TRAINERS ·ANALYSING THE TIMELINE OF THE PATIENT'S DEVICE USAGE PRIOR TO THE REPORTED INCIDENT. ·REVIEWING AVAILABLE PATIENT DATA AND PARAMETERS. ·REVIEWING VIDEO RECORDINGS OF THE PATIENT USING THE SYSTEM. ·CONDUCTING A DEVICE INSPECTION BY A LIFEWARD FIELD SERVICE ENGINEER, WHO FOUND NO EVIDENCE OF MALFUNCTION. ·EVALUATING BONE DENSITY RESULTS BY AN EXTERNAL MEDICAL EXPERT (PHYSICIAN) TO HELP IDENTIFY THE POTENTIAL ROOT CAUSE. THE INJURY WAS PROBABLY CAUSED BY A COMBINATION OF THE FOLLOWING FACTORS: 1. TIGHTNESS OF THE LEFT KNEE (MILD KNEE FLEXION CONTRACTURE). 2. AT SOME UNKNOWN POINT DURING WALKING, THE LEFT FRONT KNEE BRACKET (FKB) ROTATED DOWNWARD, CAUSING THE TOP (NON-CUSHIONED) PART OF THE FKB TO DIRECTLY PRESS ON THE AREA BELOW THE LEFT KNEE JOINT (TIBIA). THE POSSIBILITY OF FKB MECHANICAL FAILURE WAS ELIMINATED AS THE FKBS WERE INVESTIGATED BY R&D AND QA TEAM AND THERE WAS NO DEFECT FOUND THAT CAN BE RELATED TO THE INJURY. · THE ROTATIONAL MOVEMENT OF THE FKB IS AN INTENTIONAL DESIGN FEATURE, IMPLEMENTED TO COMPENSATE FOR VARIATIONS IN TIBIAL ORIENTATION DURING USE OF THE DEVICE. · THE REASON WHY THE FKB WAS SHIFTING DOWNWARD CAUSING THE TOP (NON-CUSHIONED) PART OF THE FKB TO DIRECTLY PRESS ON THE AREA BELOW THE LEFT KNEE JOINT (TIBIA) - IS NOT CLEAR. · POSSIBLE CAUSES: O EXTENSOR TONE OF THE USER MAY HAVE CONTRIBUTED TO THE BODY SHIFTING AWAY FROM THE INJURED LEFT KNEE CAUSING ADDITIONAL SPACE IN THE AREA AND ALLOWING FKB ROTATION. O THE FKB STRAP MAY HAVE BEEN LOOSE AND FKB ROTATED DOWNWARD WITH MOVEMENT OF THE LEG. 3. PROBABLE CONTRIBUTING FACTORS: · PATIENT BODY STRUCTURE AND FITTING: O PATIENT'S LEFT KNEE HAD LIMITED RANGE OF MOTION BUT WITHIN THE APPROPRIATE RANGE REQUIRED FOR THESE OF THE DEVICE. O VERY THIN BODY STRUCTURE WITH LIMITED MUSCLE OR FAT MASS - CREATING DIFFICULTY FITTING THE PELVIC BAND AND STRAPPING THE PATIENT (THE PELVIC WAS ADJUSTED MID-SESSION FROM V2 TO V1). THERE WAS NO EVIDENCE OF MECHANICAL FAILURE OF THE REWALK DEVICE CAUSING THE INJURY. CAPA0230 WAS INITIATED: UPDATING THE USER AND THERAPIST MANUALS AND THE TRAINING PRESENTATION WITH ADDITIONAL WARNINGS.

    Description of Event or Problem · 0

    TOWARDS THE END OF THE TRIAL SESSION, IT WAS NOTED THAT THE PATIENT WAS MISALIGNED WITH THE DEVICE. THE LEFT HIP HAVE DROPPED AND THE FRONT KNEE BRACKET (FKB) WAS ROTATED DOWNWARD. THE SESSION WAS DISCONTINUED, A SKIN CHECK WAS DONE, AND IT WAS NOTED THAT HER LEFT KNEE WAS SIGNIFICANTLY MORE SWOLLEN. TWO DAYS AFTER THE TRIAL SESSION THE PATIENT REPORTED TO THE REWALK CLINICAL TRAINING MANAGER THAT SHE WAS DIAGNOSED WITH A FRACTURE AT THE LEFT KNEE. THE INCIDENT WAS RECORDED UNDER CUSTOMER COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 0

    TOWARDS THE END OF THE TRIAL SESSION, IT WAS NOTED THAT THE PATIENT WAS MISALIGNED WITH THE DEVICE. THE LEFT HIP HAVE DROPPED AND THE FRONT KNEE BRACKET (FKB) WAS ROTATED DOWNWARD. THE SESSION WAS DISCONTINUED, A SKIN CHECK WAS DONE, AND IT WAS NOTED THAT HER LEFT KNEE WAS SIGNIFICANTLY MORE SWOLLEN. TWO DAYS AFTER THE TRIAL SESSION THE PATIENT REPORTED TO THE REWALK CLINICAL TRAINING MANAGER THAT SHE WAS DIAGNOSED WITH A FRACTURE AT THE LEFT KNEE. THE INCIDENT WAS RECORDED UNDER CUSTOMER COMPLAINT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1667192 REWALK PERSONAL P6.0 POWERED EXOSKELETON PHL LIFEWARD LTD. REWALK PERSONAL P6.0

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention