MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2015-10-07 for EKSO NA manufactured by Ekso Bionics, Inc..
[28058042]
Device to be returned to mfr for eval. Based on previous similar malfunctions, mfr determined that fasteners sheared under bending stresses greater than the fatigue load of the fastener (b)(4) causing the foot place to partially separate from the ankle ((b)(4)). Failure mode of fasteners was from bending fatigue, however root cause analysis of failure mode is still under investigation and results are pending completion of eval. Additional info follow-up will be submitted when the following info becomes available: this device is currently registered under procode bxb as indicated. This device is currently pending 510 (k) approval under procode phl. Eval results and conclusion - as root cause analysis is still pending eval. Remedial action - root cause analysis is still pending eval. Note to fda: mdr prepared by deadline, but submitted past deadline date since production webtrader account is still pending activation.
Patient Sequence No: 1, Text Type: N, H10
[28058043]
[device #4 similar to mdr # 3009495988-2015-00001]. Customer reported that the malfunction occurred while walking. Physical therapist noticed that the foot plate had come partially separated from the device. Physical therapist was able to lower the pt into a chair and was safely removed from the device. The pt sustained no injuries and no medical follow-up or intervention was needed. No physical therapists, therapists, or third persons have been affected or injured.
Patient Sequence No: 1, Text Type: D, B5
[40345977]
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
[40345978]
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 | 3009495988-2015-00005 |
| MDR Report Key | 5141800 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2015-10-07 |
| Date of Report | 2015-09-24 |
| Date of Event | 2015-08-25 |
| Date Mfgr Received | 2015-08-25 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2015-10-09 |
| 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 S STE 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 | EKSOexerciser, powered |
| Product Code | PHL |
| Date Received | 2015-10-07 |
| Model Number | EKSO |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2015-10-07 |