MAUDE Adverse Event Report: REWALK ROBOTICS LTD REWALK PERSONAL; POWERED EXSOSKELETON, PRODUCT CODE: PHL

Model Number	PERSONAL
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	09/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cause for the user fall was loss of balance; however, it is not clear how the user lost her balance.With the available data it can be concluded that: the system was inspected and no malfunction was found.The user tried to walk alone - which is against our recommendations that every rewalk user, no matter how skilled, should have a trained rewalk companion assist him during use.The cause for the fall was the user's momentary loss of balance, probably while turning around to climb the stairs.A fitting adjustment was done about 20 min before the fall and was approved by the user - according to the ww training manager this fitting could make an impact on balance but is unlikely to cause the fall.
Event or Problem Description
During walking with the rewalk device the patient lost balance and fell backwards; the patient (she) hit the ground with the back of her head.The health situation was unclear and she was taken to the hospital.The immediate outcome after the fall was: brachial plexus stretch left and right; brachial plexus compression left due to a hematoma; headache' the user was hospitalized and released after few days.

• Brand Name: REWALK PERSONAL
• Common Device Name: POWERED EXSOSKELETON, PRODUCT CODE: PHL
• Manufacturer (Section D): REWALK ROBOTICS LTD; 3 hatnufa st. (6th floor); yokne'am 2069203, ; IS
• MDR Report Key: 8155073
• Report Number: 3007615665-2018-00017
• Device Sequence Number: 1694076
• 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: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 12/12/2018
• Report Date (Section F): 09/28/2018

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: Lay User/Patient
• Device Model Number: PERSONAL
• Device Catalogue Number: 50-20-0004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/12/2018
• Device Age: 3 MO
• Event Location: Other
• Date Report to Manufacturer: 09/28/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 12/12/2018
• 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: 28 YR
• Patient Weight: 60