MAUDE Adverse Event Report: EKSO BIONICS EKSO; POWERED EXOSKELETON

Model Number	EKSO-1.1
Health Effect - Clinical Codes	Bruise/Contusion (1754); Muscle Spasm(s) (1966); Swelling (2091); No Code Available (3191)
Date of Event	06/09/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Patient w/ thoracic spinal cord injury & flaccid paraplegia.Following use of the ekso bionic gate device, the patient had swelling of the right ankle & foot.This was the patient's first time using the device.A trained physical therapist & pt assistant were present during the session and reported that the patient had a good fit and did well.No skin issues were noted at the end of session.The next day, the patient reported having spasms in her leg and noted some swelling.When she removed her shoe, she noticed that her r ankle looked bruised.Physical therapy was called and the patient was assessed.The patient was found to have swelling in r foot medial ankle & distal part of lower leg and bruising below the medial malleolus.A physician was notified and x-ray was completed.X-ray reported an "avulsion of unknown chronicity over the medial talus body and lateral malleolus.No obvious acute fractures." casting was not needed, but the patient was treated with ice, compression, and an aso brace.The patient's husband had a video of her walking in the ekso- this was reviewed and noted that her r ankle was supinating inside the foot strap of the ekso (x372 steps taken during that session).The patient's ankle moved in a frontal plane rather than a a/p plane possibly causing stress to the lateral ankle.Ultimately, it is believed that the patient's dorsiflexion was overestimated and perhaps, additional necessary adjustments to the ekso were not made.It is staff's perception that the device did not cause this injury, but perhaps, lack of visualization of the maladjustment was the problem.Typically, 2 physical therapists are present/assist new spinal cord injury patients when using the ekso.In this reported case, the patient was not a new injury, and instead of 2 therapists being present, there was 1 physical therapist & 1 pt assistant.As of filing of this report, there are #134,808 steps of use on the device.

• Brand Name: EKSO
• Common Device Name: POWERED EXOSKELETON
• Manufacturer (Section D): EKSO BIONICS; 1414 harbour way s; ste 1201; richmond CA 94804
• MDR Report Key: 6740206
• Report Number: 6740206
• Device Sequence Number: 1148198
• Product Code: PHL
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/30/2017
• Report Date (Section F): 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EKSO-1.1
• Other Device ID Number: 011208002
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 5 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/26/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO OTHER THERAPIES; YES, A WALKER WAS BEING USED IN CONJUNCTION WITH T
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Date Report Sent to FDA: 06/26/2017