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

Model Number	PERSONAL
Medical Device Problem Code	Unintended Collision (1429)
Health Effect - Clinical Code	Fall (1848)
Date of Event	02/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The user fell from an unknown reason.According to the testimony there was no system issues that caused the fall and the injury.In addition: the user crashed at home while training with his certified physiotherapist.He wanted to go around the table and fell for unexplainable reasons.2.There were no system disturbances related to the fall.The fall happened while walking.As a companion in the training his certified physiotherapist was on site.The user needs little support when walking.He is already very independent in the training.The physiotherapist is always at his side during the training.The two have completed one in-house training.5.The device is a personal system.6.The user has already been in his system and has been training regularly for more than a year.He has completed the basic training and is already partly in the advanced training.
Event or Problem Description
The user has crashed in his home while training in his system p-60-1296.He has trained with his certified physiotherapist.He wanted to go around the table and fell for unexplainable reasons.

• 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: 7393486
• Report Number: 3007615665-2018-00004
• Device Sequence Number: 10365240
• Product Code: PHL
• 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
• Type of Report: Initial
• Report Date (Section B): 04/03/2018
• Report Date (Section F): 03/28/2017

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: No Information
• Device Model Number: PERSONAL
• Device Catalogue Number: 50-20-0004
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/28/2017
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 03/28/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2017
• Initial Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 54 YR
• Patient Weight: 85