MAUDE Adverse Event Report: EKSO BIONICS EKSOGT; POWERED EXOSKELETON

Model Number EKSOGT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

During a recent review of incidents, it was determined that although an mdr form was completed at the time of the incident, it was not successfully submitted to fda.Because the incident was determined to be reportable, it is being retroactively reported.

Event Description

Patient had a femur fracture in (b)(6) 2020.Began walking again until a massive stroke in april.Began physical therapy in september with a follow up x-ray in (b)(6) in which the doctor stated the bone had not completely healed but she was given a bone simulator and cleared for physical therapy.Patient participated in about 2 weeks of utilizing the tilt table and 3 weeks of utilizing the standing frame and was able to tolerate 20 minutes in the standing frame prior to attempting to use the ekso device.She did not have any issues with weight bearing in either the standing frame or tilt table.While beginning to stand in the ekso, the patient reported pain in her lower back.She was seated and the pain subsided.The patient generally has back pain with all transfers that subside so it was not unusual for her to have pain.An attempt for a second stand was attempted, but the patient stated she was in too much pain to continue.The patient was transferred to a wheel chair and experienced pain again in her leg that was previously fractured when it was placed onto the leg rest.Once situated, subsequent x-ray the next day found the femur was still fractured.Surgery was recommended but has not been scheduled due to her condition regarding the stroke.

• Brand Name: EKSOGT
• Type of Device: POWERED EXOSKELETON
• Manufacturer (Section D): EKSO BIONICS; 1414 harbour way south; suite 1201; richmond CA 94804
• Manufacturer (Section G): EKSO BIONICS; 1414 harbour way south; suite 1201; richmond CA 94804
• Manufacturer Contact: charlie wu ; 1414 harbour way south; suite 1201; richmond, CA 94804 ; 6173065917
• MDR Report Key: 13977353
• MDR Text Key: 288382067
• Report Number: 3009495988-2022-00001
• Device Sequence Number: 1
• Product Code: PHL
• Combination Product (y/n): N
• PMA/PMN Number: K200574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EKSOGT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 77 YR
• Patient Sex: Female