REWALK PERSONAL P6.0

Description of Event or Problem

PATIENT REPORTED HIP PAIN WHILE WALKING DURING A TRAINING SESSION ON (B)(6) 2024. AS A PRECAUTION, THE SESSION WAS STOPPED. DUE TO THE MINIMAL NATURE OF THE PAIN, THE PATIENT PARTICIPATED IN ANOTHER TRAINING SESSION ON (B)(6) 2024. PRIOR TO THE SESSION, THE PATIENT PERFORMED STRETCHING EXERCISES. DURING THE SESSION, THE PATIENT EXPERIENCED DISCOMFORT WHILE STANDING AND INCREASED PAIN WHEN ATTEMPTING TO TAKE A FEW STEPS. CONSEQUENTLY, THE SESSION WAS STOPPED, AND THE PATIENT EXITED THE DEVICE. ON (B)(6) 2024, A LIFEWARD REPRESENTATIVE RECEIVED A MESSAGE FROM THE PATIENT INDICATING THAT HE HAD BEEN DIAGNOSED WITH A RIGHT FEMORAL NECK FRACTURE. THIS INCIDENT WAS DOCUMENTED UNDER CUSTOMER COMPLAINT NUMBER: (B)(4).

Additional Manufacturer Narrative

FINAL REPORT AND INVESTIGATION MAIN FINDINGS: DATE: JULY 24 2025 1. THE INVESTIGATION ACTIVITIES INCLUDED THE FOLLOWING: ·REVIEWING DEVICE RECORDS. ·INTERVIEWING THE CLINICAL TRAINER AND THE PATIENT. ·REVIEWING VIDEO RECORDINGS OF THE PATIENT USING THE SYSTEM. ·ANALYSING THE TIMELINE OF THE PATIENT'S DEVICE USAGE PRIOR TO THE REPORTED INCIDENT. ·REVIEWING AVAILABLE PATIENT DATA AND PARAMETERS. ·CONDUCTING A DEVICE INSPECTION BY A LIFEWARD FIELD SERVICE ENGINEER, WHO FOUND NO EVIDENCE OF MALFUNCTION. ·EVALUATING MEDICAL IMAGING AND BONE DENSITY RESULTS BY AN EXTERNAL MEDICAL EXPERT (PHYSICIAN) TO HELP IDENTIFY THE POTENTIAL ROOT CAUSE. 2. THE RIGHT FEMORAL NECK FRACTURE WAS LIKELY CAUSED BY WEIGHT-BEARING ON THE RIGHT HIP WITH DIMINISHED BONE MINERAL DENSITY AND MASS - DURING THE AMBULATION MODE AND WAS NOT RELATED TO A FALL OR ANY OTHER POTENTIALLY TRAUMATIC EVENT, SUCH AS ROUTINE PASSIVE RANGE OF MOTION PERFORMED BY PHYSICAL THERAPY. THE RIGHT FEMORAL FRACTURE WAS MOST LIKELY NOT DUE TO ANY ORTHOTIC SYSTEM PROBLEM. BASED ON ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE INJURY WAS CAUSED BY DEVICE MALFUNCTION OR MISUSE. 3. CAPA0230 WAS INITIATED: UPDATING THE USER AND THERAPIST MANUALS AND THE TRAINING PRESENTATION WITH ADDITIONAL WARNINGS.

Description of Event or Problem

PATIENT REPORTED HIP PAIN WHILE WALKING DURING A TRAINING SESSION ON OCTOBER 25, 2024. AS A PRECAUTION, THE SESSION WAS STOPPED. DUE TO THE MINIMAL NATURE OF THE PAIN, THE PATIENT PARTICIPATED IN ANOTHER TRAINING SESSION ON OCTOBER 28, 2024. PRIOR TO THE SESSION, THE PATIENT PERFORMED STRETCHING EXERCISES. DURING THE SESSION, THE PATIENT EXPERIENCED DISCOMFORT WHILE STANDING AND INCREASED PAIN WHEN ATTEMPTING TO TAKE A FEW STEPS. CONSEQUENTLY, THE SESSION WAS STOPPED, AND THE PATIENT EXITED THE DEVICE. ON (B)(6) 2024, A LIFEWARD REPRESENTATIVE RECEIVED A MESSAGE FROM THE PATIENT INDICATING THAT HE HAD BEEN DIAGNOSED WITH A RIGHT FEMORAL NECK FRACTURE. THIS INCIDENT WAS DOCUMENTED UNDER CUSTOMER COMPLAINT NUMBER:(B)(4)..