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 Codes	Unspecified Vascular Problem (4441); Insufficient Information (4580)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had been using a rewalk device for several years.On (b)(6) 2024, the patient used a newly delivered rewalk device for the first time for approximately 30 minutes.The settings on the new device were the same as his previous device.No issues were reported during the fitting process and there were no reports of device malfunction before or during use.On october 19, 2024, lifeward representative received a message from the patient, reporting that several days after his session with the new rewalk device on (b)(6) 2024, he noticed his right foot's toes turning blue.He attempted self-care at home without improvement, and after 12 days, sought medical attention, leading to his hospitalization.Subsequently, the patient reported undergoing an amputation of the lateral part of his forefoot.The incident was recorded under customer complaint number: (b)(4).
Additional Manufacturer Narrative
Final report date: june 30 2025 1.The investigation activities included the following: · review of device records.· interviews with the clinical trainer and with the patient.· reviewing the timeline of the patient usage of the device · available patient data and parameters · a lifeward field service engineer inspected the device and found no evidence of malfunction.2.The right footplate of the device, which had been in direct contact with the patient's injured leg, was returned for further investigation by the r&d and quality teams.No malfunctions were identified.3.The customer declined the requests from lifeward to share additional medical information.4.The available information (pictures of the foot toes) was reviewed and evaluated by an external medical/clinical expert (physician), and it was determined that: the toe amputation was a complication of vascular disease, possibly from thromboembolism or cholesterol embolization from atherosclerotic plaque.The rewalk device cannot be considered a risk factor for the development of any vascular disease or in embolization in a vascular disease.The medical complication was not related to the usage of the rewalk device.5.Based on all available information, there is no evidence to suggest that a device malfunction caused the injury.Additional notes: there were no similar incidents before or after the reported incident.There are no required actions as it is concluded that the medical complication was not related to the usage of the rewalk device.
Event or Problem Description
The patient had been using a rewalk device for several years.On (b)(6) 2024, the patient used a newly delivered rewalk device for the first time for approximately 30 minutes.The settings on the new device were the same as his previous device.No issues were reported during the fitting process and there were no reports of device malfunction before or during use.On (b)(6) 2024, lifeward representative received a message from the patient, reporting that several days after his session with the new rewalk device on (b)(6) 2024, he noticed his right foot's toes turning blue.He attempted self-care at home without improvement, and after 12 days, sought medical attention, leading to his hospitalization.Subsequently, the patient reported undergoing an amputation of the lateral part of his forefoot.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: 20682019
• Report Number: 3007615665-2024-00003
• Device Sequence Number: 7262582
• Product Code: PHL
• UDI-Device Identifier: 00861803000303
• UDI-Public: (01)00861803000303
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2024
• Supplement Date Received by Manufacturer: 10/19/2024
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White