MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-06 for EKSO manufactured by Ekso Bionics, Inc..
[110224110]
Patient Sequence No: 1, Text Type: N, H10
[110224111]
Patient with spinal cord injury and paraplegia using ekso bionic gait device along with bilateral forearm crutches. Per report of physical therapist (pt), when patient attempted the sit-to-stand process, the ekso device hesitated. The patient was assisted back to sitting where the sit-to-stand procedure was completed again and successful. The patient ambulated approximately 60 feet, then stated that she felt like her left hip was higher than the right hip. The pt assessed the device noting the left upper leg length was off by "4" notches. Per pt, this is a very small adjustment. (it is unknown if the setting was initially off by 4 or if the change occurred during the attempted sit-to-stand process. ) the patient was lowered to sitting in chair. The left leg was re-set to correct settings. Per report by pt, the patient was noted to have mild edema in right knee, but wanted to resume walking/therapy. Again, the patient had difficulty with the sit-to-stand procedure. Pt reported the device "hesitated" and moderate assistance was required to assist patient to standing. After this, patient ambulated approximately 200 feet with two times to stop and re-start her gait pattern. Per the pt report, the patient did continuously re-position the left crutch for right stance, as she was not placing the right crutch laterally enough to allow full weight shift. The patient required moderate to max assist while advancing the left crutch. Up time = 27:29 minutes. Walk time = 14:04 minutes. Total steps = 334. The patient completed physical therapy. No increase in edema was noted. No open skin issues were noted. Pt reported mild pressure marks on tibias that went away within 2 minutes. No changes were appreciated in spasticity, and no other signs and symptoms were noted. Following return home, the patient called the pt to report swelling in the right knee. This was treated at home with cold pack, e-stim, and elevation but no improvement was noted. The next day, the patient followed up with orthopedics. Imaging was completed showing a right tibial plateau fracture. The pt assisting the patient denied any alarms or other concerns with the equipment. The only concern noted was the hesitation with the sit to stand procedure that required moderate assistance to get the patient to a standing position. In interviews with the pt involved, it was reported the patient has a "standing program" at home where long leg splints are used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7572849 |
| MDR Report Key | 7572849 |
| Date Received | 2018-06-06 |
| Date of Report | 2018-06-04 |
| Date of Event | 2018-05-15 |
| Report Date | 2018-06-01 |
| Date Reported to FDA | 2018-06-01 |
| Date Reported to Mfgr | 2018-06-01 |
| Date Added to Maude | 2018-06-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EKSO |
| Generic Name | POWERED EXOSKELETON |
| Product Code | PHL |
| Date Received | 2018-06-06 |
| Model Number | EKSO |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EKSO BIONICS, INC. |
| Manufacturer Address | 1414 HARBOUR WAY SOUTH SUITE 1201 RICHMOND CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-06 |