MAUDE Adverse Event Report: Lifeward Ltd. ReWalk 7 Personal Exoskeleton; POWERED EXOSKELETON

Model Number	ReWalk 7 Personal Exoskeleton
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	09/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, during two rewalk trial sessions, the patient underwent repeated unsuccessful sit-to-stand attempts, each followed by a controlled return to sitting.No falls, uncontrolled movement, abnormal sound, or device malfunction were reported during the sessions.No pain, bruising, skin abnormality, or other evidence of injury was reported during or immediately after the sessions.On (b)(6) 2026 - the patient reported bruising and swelling in the left leg.The lifeward team advised patient to seek medical attention.On (b)(6) 2026 - the patient reported she was diagnosed with left tibia/fibula fracture requiring a cast for approximately 8 weeks.The exact location of the fracture was not reported.The incident is currently under investigation.
Additional Manufacturer Narrative
The root cause is under investigation.

• Brand Name: ReWalk 7 Personal Exoskeleton
• 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 (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: 50913496
• Report Number: 3007615665-2026-00003
• Device Sequence Number: 14897070
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: Health Professional
• Device Model Number: ReWalk 7 Personal Exoskeleton
• Device Catalogue Number: 50-20-0005
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2025
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 110 LB
• Patient Race: White