MAUDE Adverse Event Report: REWALK ROBOTICS LTD. REWALK PERSONAL; POWERED EXOSKELETON

Model Number	PERSONAL
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Upon standing (the company representative who was in touch with the user believes it was the second sit to stand during the session), the left hand (lh) front knee bracket (fkb) cracked and the device returned to sit position.The user went to the hospital and was diagnosed with broken leg (right leg).

• Brand Name: REWALK PERSONAL
• Common Device Name: POWERED EXOSKELETON
• Manufacturer (Section D): REWALK ROBOTICS LTD.; 3 hatnufa st. (6th floor); yokne'am, israel 20692 03; IS 2069203
• MDR Report Key: 7385462
• Report Number: 3007615665-2018-00001
• Device Sequence Number: 1633398
• Product Code: PHL
• UDI-Device Identifier: 00861803000303
• UDI-Public: (01)00861803000303
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Remedial Action: Recall,Notification
• Type of Report: Initial
• Report Date (Section B): 03/15/2018
• Report Date (Section F): 03/15/2018

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: Physical Therapist
• Device Model Number: PERSONAL
• Device Catalogue Number: 50-20-0004
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/27/2018
• Device Age: 8 MO
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 03/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0944-2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Weight: 70
• Date Report Sent to FDA: 03/15/2018