BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REWALK PERSONAL

    MDR report key: 7443774 · Received April 19, 2018

    Report

    Report Number
    3007615665-2018-00010
    Event Type
    Injury
    Date Received
    April 19, 2018
    Date of Event
    January 11, 2016
    Report Date
    April 19, 2018
    Manufacturer
    REWALK ROBOTICS LTD.
    Product Code
    PHL
    PMA / PMN Number
    K160987
    Removal / Correction Number
    Z-0944-2018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED HEREIN WAS DISCLOSED TO THE FDA ON 3 OCCASIONS IN A ROOT CAUSE ANALYSIS ((B)(4)) WHICH WAS PART OF; ADDITIONAL INFORMATION RESPONSE (MDR # 3007615665-2017-00003) DATED AUG 10, 2017. ADDITIONAL INFORMATION RESPONSE (MDR # 3007615665-2017-00004) DATED AUG 23, 2017. CLASS 2 DEVICE RECALL REWALK PERSONAL 6.0 (RECALL NUMBER Z-0944-2018, RECALL EVENT ID (B)(4).

    Description of Event or Problem · 1

    INITIAL FITTING AND TRAINING SESSION (B)(6) 2016. TWO ADDITIONAL TRAINING SESSIONS (B)(6) 2016. THE PATIENT HAD UNDERGONE THE SECOND TRAINING ON THE REWALK P-6.0 AT REWALK ROBOTICS INC.(B)(4) OFFICE. THE TARGET WAS TO TRAIN ON P-6.0 TO FURTHER INCREASE THE PATIENT SKILLS USING THE UNIT. THE PATIENT HAD UNDERGONE THE SECOND TRAINING ON THE REWALK P-6.0 AT REWALK ROBOTICS INC. (B)(4) OFFICE. THE TARGET WAS TO TRAIN ON P-6.0 TO FURTHER INCREASE THE PATIENT SKILLS USING THE UNIT. THE PATIENT USED THE UNIT FITTED ON (B)(6). THE PATIENT DONNED THE P-6.0 ASSISTED BY THE PT AND HAD THE CRUTCHES ADJUSTED. THE INITIAL 'SIT TO STAND' WAS INTERRUPTED BY WHAT SEEMED LIKE A MECHANICAL BLOCK THAT SOUNDED AN AUDIBLE CRACK (PLASTIC) FROM THE LEFT SIDE OF THE WAIST PACK/HIP JOINT. THERE SEEMED TO BE MORE KNEE FLEXION BILATERALLY THAN SHOULD BE DURING STANDING. THE PATIENT WAS TRANSFERRED OUT OF THE DEVICE. BOTH THE PATIENT AND THE DEVICE WERE CHECKED. THE PATIENT WAS OK WITH THE EXCEPTION OF SOME SORENESS TO THE UPPER TRAPEZIUS FROM THE CRUTCHES. NO VISIBLE DAMAGE OF THE REWALK WAS OBSERVED. THE PATIENT THEN WALKED (USING THE REWALK) FOR 15-20 MINUTES. THE PATIENT'S POSITION RELATIVE TO THE FKB WAS CHECKED BY OPENING THE ABOVE KNEE BUCKLES WHILE THE PATIENT WAS STANDING. NO POSITION SHIFT WAS NOTICED AND NO DISCOMFORT WAS REPORTED BY THE PATIENT. THREE ADJUSTMENTS WERE MADE (LOWER LIMB LENGTH, PELVIC POSITION, AND FKB) AND ANOTHER WALK SESSION BEGAN. WHILE STANDING THE PATIENT TILTED FORWARD BUMPING INTO AN ENGINEER WHO HELPED THE PATIENT REGAIN BALANCE. NO INJURIES OR ADVERSE EVENTS WERE NOTED. THE PATIENT WALKED FOR ANOTHER 15-20 MINUTES, WHEN THE PATIENT TIRED 'STAND TO SIT' WAS PERFORMED AND THE REWALK WAS DOFFED. THE PATIENT NOTED A RELEASE SENSATION AND A 'CURRENT' IN HER LEG WHEN THE RIGHT FKB WAS RELEASED. THE PATIENT WAS INSTRUCTED TO PERFORM A SKIN CHECK, SHE STATED THERE WERE NO ISSUES WITH HER FEET YET WOULD CHECK INDEPENDENTLY. THE PATIENT LEFT THE OFFICE AT 15:45 WITHOUT INCIDENT AND WITHOUT ANY NOTICEABLE PHYSICAL DEFORMITIES. THE PATIENT CALL AT 18:17 REPORTING WHITENESS AND SWELLING OF HER RIGHT KNEE AND LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288588 REWALK PERSONAL POWERED EXOSKELETON PHL REWALK ROBOTICS LTD. PERSONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention