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	05/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information provided herein was disclosed to the fda on 3 occasions in a root cause analysis ((b)(4)) which was part of; additional information response (mdr # 3007615665-2017-00003) dated aug 10, 2017; additional information response (mdr # 3007615665-2017-00004) dated aug 23, 2017; class 2 device recall rewalk personal 6.0 (recall number z-0944-2018, recall event id (b)(4)).
Event or Problem Description
The user reported swollen left ankle.

• 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: 7443771
• Report Number: 3007615665-2018-00009
• Device Sequence Number: 1991919
• Product Code: PHL
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 04/19/2018
• Report Date (Section F): 05/10/2017

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: Other
• Device Model Number: PERSONAL
• Device Catalogue Number: 50-20-0004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/10/2017
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/10/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2017
• Initial Report FDA Received Date: 04/19/2018
• 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: 58 YR
• Patient Weight: 94