MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2015-08-06 for EKSO EKSO GT NA manufactured by Ekso Bionics, Inc..
[24095716]
Affected items were returned to manufacturer ((b)(4)) for evaluation. Manufacture determined that fasteners sheared under bending stresses greater than the fatigue load of the fastener causing the foot plate to separate from the ankle. Some evidence of damage was identified which may be indicative of misuse or device handling issue. Failure mode of fasteners was from bending fatigue, however root cause analysis of failure mode is still under investigation and affected items have been retained. This device was repaired and returned to the customer. Additional information follow-up will be submitted when the following information becomes available. (d2b) this device is currently registered under procode bxb as indicated in (d2b). This device is currently pending 510(k) approval under procode phl. Evaluation results and conclusion: as root cause analysis is still pending evaluation. Remedial action: root cause analysis is still pending evaluation.
Patient Sequence No: 1, Text Type: N, H10
[24095717]
Customer reported that during use the left foot plate became separated from the rest of the ankle on the device. Patient was safely removed from the device ans sustained no injury. No physical therapists, or third persons have been affected or injured.
Patient Sequence No: 1, Text Type: D, B5
[40345714]
Root cause was under-torqued (preload) fasteners and loss of joint tension due to the degenerative compression of the carbon fiber footplate. Low risk failure due to safeguards in place eliminating any realistic possibility of patient harm. Design improvements were identified, which further increase the durability of the device. Improvements to be implemented at the next routine service period.
Patient Sequence No: 1, Text Type: N, H10
[40345715]
This event did not lead to an injury and there have been no injuries reported since the mdr was filed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009495988-2015-00001 |
| MDR Report Key | 5021117 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2015-08-06 |
| Date of Report | 2015-08-05 |
| Date of Event | 2015-07-06 |
| Date Mfgr Received | 2015-07-06 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2015-08-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| 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 | 5109841761 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EKSO |
| Generic Name | EKSO GT |
| Product Code | PHL |
| Date Received | 2015-08-06 |
| Returned To Mfg | 2015-07-10 |
| Model Number | EKSO GT |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | EKSO BIONICS, INC. |
| Manufacturer Address | RICHMOND CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-06 |