MAUDE Adverse Event Report: EKSO BIONICS, INC. EKSO; EKSOexerciser, powered

Model Number EKSO

Device Problems Detachment Of Device Component (1104); Fracture (1260)

Patient Problem Muscle Weakness (1967)

Event Date 08/25/2015

Event Type  malfunction  

Manufacturer Narrative

Device to be returned to mfr for eval.Based on previous similar malfunctions, mfr determined that fasteners sheared under bending stresses greater than the fatigue load of the fastener (b)(4) causing the foot place to partially separate from the ankle ((b)(4)).Failure mode of fasteners was from bending fatigue, however root cause analysis of failure mode is still under investigation and results are pending completion of eval.Additional info follow-up will be submitted when the following info becomes available: this device is currently registered under procode bxb as indicated.This device is currently pending 510 (k) approval under procode phl.Eval results and conclusion - as root cause analysis is still pending eval.Remedial action - root cause analysis is still pending eval.Note to fda: mdr prepared by deadline, but submitted past deadline date since production webtrader account is still pending activation.

Event Description

[device #4 similar to mdr # 3009495988-2015-00001].Customer reported that the malfunction occurred while walking.Physical therapist noticed that the foot plate had come partially separated from the device.Physical therapist was able to lower the pt into a chair and was safely removed from the device.The pt sustained no injuries and no medical follow-up or intervention was needed.No physical therapists, therapists, or third persons have been affected or injured.

Manufacturer Narrative

Root cause was under-torqued (preload) fasteners and loss of joint tension due to the degenerative compression of the carbon fiber footplate.Remedial action: a bearing plate will be placed between the carbon fiber footplate and ankle box, and washers will be placed under the fasteners along with thread locker.Since this failure mode represents a low risk of injury the corrective actions will be made at the next routine service period.

Event Description

This event did not lead to an injury and there have been no injuries reported since the mdr was filed.

• Brand Name: EKSO
• Type of Device: EKSOexerciser, powered
• Manufacturer (Section D): EKSO BIONICS, INC. ; richmond CA
• Manufacturer Contact: doug humphrey ; 1414 harbour way s ste 1201; richmond, CA 94804 ; 5109841761
• MDR Report Key: 5141800
• MDR Text Key: 28058042
• Report Number: 3009495988-2015-00005
• Device Sequence Number: 0
• Product Code: PHL
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EKSO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 64