MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-02 for EKSO EKSO 1.1 manufactured by Ekso Bionics.
[122453981]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[122453982]
Pt is a t4 sci. She has a regular standing program and walks with kafos. She had used the ekso last (b)(6) 2017 and did well but had a r ankle sprain as her r ankle tried to supinate in the ekso. She returned to try the ekso again in (b)(6) 2017 and this time has been wearing a r ankle brace to prevent this and has had no issues. She has been using the ekso 1 x week most of this time. She has been doing well with no issues. On (b)(6) 2018, we had difficulty with sit to stand with not being able to complete standing. On the third attempt we were able to lean forward more and push up to stand with the device slow to acknowledge standing. Pt was able to ambulate 60ft. Pause due to feeling of hips being off. Pt adjusted l leg length 4 points as is was slightly longer than the r. (in sitting). Again had difficulty with sit to stand, but able to push up with extra assist by pt and pt on 2nd attempt. Once up pt was able to ambulate another 100ft. Lowered to sit and ekso removed. Noted r knee swelling. Swelling remained overnight and pt sent to dr. X-ray showed r tibia plateau fx.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009495988-2018-00001 |
| MDR Report Key | 7928077 |
| Date Received | 2018-10-02 |
| Date of Report | 2018-10-02 |
| Date of Event | 2018-05-15 |
| Date Mfgr Received | 2018-05-18 |
| Device Manufacturer Date | 2012-03-03 |
| Date Added to Maude | 2018-10-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| 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 | 2018-10-02 |
| Returned To Mfg | 2018-06-08 |
| Model Number | EKSO 1.1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-10-02 |