MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-25 for EKSO EKSO-1.1 manufactured by Ekso Bionics.
[80928344]
Patient Sequence No: 1, Text Type: N, H10
[80928345]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6740206 |
| MDR Report Key | 6740206 |
| Date Received | 2017-07-25 |
| Date of Report | 2017-06-30 |
| Date of Event | 2017-06-09 |
| Report Date | 2017-06-26 |
| Date Reported to FDA | 2017-06-26 |
| Date Reported to Mfgr | 2017-06-26 |
| Date Added to Maude | 2017-07-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 2017-07-25 |
| Model Number | EKSO-1.1 |
| ID Number | 011208002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EKSO BIONICS |
| Manufacturer Address | 1414 HARBOUR WAY S STE 1201 RICHMOND CA 94804 US 94804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-25 |