MAUDE Adverse Event Report: LIFEWARD LTD. REWALK PERSONAL P6.0; POWERED EXOSKELETON

Model Number	REWALK PERSONAL P6.0
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was using the rewalk device for a total of 7 training sessions during and (b)(6) 2024.On(b)(6) 2024, 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).
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.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.Root cause summary based on all available information, there is no evidence to suggest that the injury was caused by a device malfunction or misuse.Probable cause: the patient had an increase in overall spasticity due to a new diagnosis of urinary tract infection.The sudden left lower extremity spasm occurring during the sit-to-stand transition was witnessed to bring the patellar tendon weight-bearing area of her left proximal tibia into forceful contact with the proximal tibial restraining bar of the rewalk device.The direct trauma resulted in the bilateral comminuted left proximal tibial fractures.3.Capa: 0230 was initiated: updating the user and therapist manuals and the training presentation with additional warnings.
Event or Problem Description
The patient was using the rewalk device for a total of 7 training sessions during on (b)(6) 2024.On (b)(6) 2024, 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).

• Brand Name: REWALK PERSONAL P6.0
• Common Device Name: POWERED EXOSKELETON
• Manufacturer (Section D): LIFEWARD LTD.; 3 hatnufa street (6th floor); p.o. box 161; yokneam ilit, 20692 03; IS 2069203
• Manufacturer Contact: ishay tal ; 3 hatnufa street (6th floor); p.o. box 161; yokneam ilit, 20692-03 ; IS 2069203
• MDR Report Key: 20275819
• Report Number: 3007615665-2024-00002
• Device Sequence Number: 11611293
• Product Code: PHL
• UDI-Device Identifier: 00861803000303
• UDI-Public: (01)00861803000303
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K221696
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: REWALK PERSONAL P6.0
• Device Catalogue Number: 50-20-0004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 09/22/2024
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American