MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2015-09-02 for EKSO EKSO GT NA manufactured by Ekso Bionics.
[40341989]
Root cause was under-torqued (preload) fasteners and loss of joint tension due to the degenerative compression of the carbon fiber footplate. Remedial action: a bearing plate will be placed between the carbon fiber footplate and ankle box, and washers will be placed under the fasteners along with thread locker. Since this failure mode represents a low risk of injury the corrective actions will be made at the next routine service period.
Patient Sequence No: 1, Text Type: N, H10
[40341990]
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 | 3009495988-2015-00004 |
| MDR Report Key | 5057614 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2015-09-02 |
| Date of Report | 2015-09-02 |
| Date of Event | 2015-08-05 |
| Date Mfgr Received | 2015-08-10 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2015-09-04 |
| 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 |
| 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 | 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 | 2015-09-02 |
| Returned To Mfg | 2015-08-10 |
| 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 |
| Manufacturer Address | RICHMOND CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-02 |