MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-26 for EKSO EKSO 1.1 manufactured by Ekso Bionics.
[91192952]
The details of the maude adverse event report ((b)(4)) were reviewed and discussed with the clinical, quality assurance and regulatory affairs departments. The conclusion of the review agrees with the perception provided in the report (based, in part, on the review of video from the session) that the injury was not caused by the device (ekso 1. 1). The injury was caused by inaccurate measuring of the range of motion (rom) of the patient's ankle and suboptimal positioning of the foot in the foot binding of the device. The report indicates that a post-session skin inspection was performed and indicates no issues. A post-session standing visual inspection may have helped with the ankle supination issues, although it is possible that the ankle may have moved slightly during the walking session. The device history record was checked, and no previous device nonconformities were found. In addition, the complaint database was reviewed for issues with this device serial number and for this customer, and no open issues with this device were found. According to the data that is available, the device is operating as designed. Ekso bionics was not initially notified about this event. The adverse event report was discovered through a search of the maude database.
Patient Sequence No: 1, Text Type: N, H10
[91192953]
The event is described by the user facility in maude adverse event report # (b)(4) on 26 june 2017. The event description from that report is copied below: "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 | 3009495988-2017-00001 |
| MDR Report Key | 6978993 |
| Date Received | 2017-10-26 |
| Date of Report | 2017-10-06 |
| Date of Event | 2017-06-09 |
| Date Mfgr Received | 2017-08-25 |
| Device Manufacturer Date | 2012-08-10 |
| Date Added to Maude | 2017-10-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DOUG HUMPHREY |
| Manufacturer Street | 1414 HARBOUR WAY SOUTH SUITE 1201 |
| Manufacturer City | RICHMOND CA 94804 |
| Manufacturer Country | US |
| Manufacturer Postal | 94804 |
| Manufacturer Phone | 5105292537 |
| Manufacturer G1 | EKSO BIONICS |
| Manufacturer Street | 1414 HARBOUR WAY SOUTH SUITE 1201 |
| Manufacturer City | RICHMOND CA 94804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EKSO |
| Generic Name | EKSO 1.1 |
| Product Code | PHL |
| Date Received | 2017-10-26 |
| Model Number | EKSO 1.1 |
| 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 SOUTH SUITE 1201 RICHMOND CA 94804 US 94804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-26 |