MAUDE Adverse Event Report: LIFEWARD LTD. REWALK 7; POWERED EXOSKELETON

Model Number	REWALK 7
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	07/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The incident is currently under investigation.Based on the information collected so far, the cause is likely related to the user's pre-existing vascular condition and not to the rewalk device.
Event or Problem Description
The following data was reported to the lifeward clinical training manager by a physical therapist at the user's training clinic: (b)(6), 2025: the user reported a pinching sensation in her right hip during use of the device.Later that same day, during a follow-up session, she reported that the pinching did not recur.(b)(6), 2025: the user cancelled her session due to swelling in her left leg.The user believes this may be related to the stents in her groin and possibly the cause of the earlier pinching sensation.(b)(6), 2025: the user visited the er and was diagnosed with blood clots in her leg.The user is awaiting consultation with her physician to determine the next steps in treatment.Status: the user is on hold from training until the medical issue is fully resolved and cleared by her healthcare provider.The incident was recorded under customer complaint number: (b)(4).
Additional Manufacturer Narrative
Final report and investigation main findings: date: october 20, 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 information provided by the patient by an external medical expert (physician) to identify the potential root cause.Medical assessment conclusion: the patient had a recurrence of pre-existing proximal lower limb venous thrombotic disease with occlusion of previously implanted venous stents.The rewalk device does not in any way interfere with the function of the vascular system or implanted vascular stents.Rewalk device use was not the cause of the patient's vascular disease or vascular disease complications.Based on the collected information, the cause is likely related to the user's pre-existing vascular condition and not to the rewalk device.
Event or Problem Description
The following data was reported to the lifeward clinical training manager by a physical therapist at the user's training clinic: on (b)(6) 2025: the user reported a pinching sensation in her right hip during use of the device.Later that same day, during a follow-up session, she reported that the pinching did not recur.On (b)(6) 2025: the user cancelled her session due to swelling in her left leg.The user believes this may be related to the stents in her groin and possibly the cause of the earlier pinching sensation.On (b)(6) 2025: the user visited the er and was diagnosed with blood clots in her leg.The user is awaiting consultation with her physician to determine the next steps in treatment.The incident was recorded under customer complaint number: (b)(4).

• Brand Name: REWALK 7
• Common Device Name: POWERED EXOSKELETON
• Manufacturer (Section D): LIFEWARD LTD.; 3 hatnufa street (6th floor); p.o. box 161; yokneam ilit, israel 20692 03; IS 2069203
• Manufacturer (Section G): 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: 22836808
• Report Number: 3007615665-2025-00001
• Device Sequence Number: 9404343
• Product Code: PHL
• UDI-Device Identifier: 00860001744514
• UDI-Public: (01)00860001744514
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K241822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

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 7
• Device Catalogue Number: 50-20-0005
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2025
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White