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	10/23/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
He incident may have happened during training.The fractures are above the position of the front knee bracket (fkb) and below the knee.Also, there is a pressure point in the height of the sacroiliac on the back.

• 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: 7385479
• Report Number: 3007615665-2018-00002
• Device Sequence Number: 11140595
• 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): 03/29/2018
• Report Date (Section F): 10/26/2017

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: Physical Therapist
• Device Model Number: PERSONAL
• Device Catalogue Number: 50-20-0004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/26/2017
• Device Age: 21 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2017
• 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: 63 YR
• Patient Weight: 80