MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-12-28 for OTTO BOCK AXTION? PROSTHETIC FOOT 1E56 1E56=N26-3-P/0 manufactured by Otto Bock Healthcare Lp.
[131718784]
[(b)(4)].
Patient Sequence No: 1, Text Type: N, H10
[131718805]
It was reported by the end-user's facility that the end-user was simply performing normal daily activities. While walking, the end-user heard a pop and observe that his axtion foot pyramid had cracked through. No fall or injury resulted from the axtion pyramid failure. Therefore, no medical attention was sought after this failure. The axtion foot could no longer be used and the defect was reported to ottobock one week after the event. All information reported back from the end-user's facility confirmed that the foot was used as instructed and within proper indications. The failure occurred within the intended use-life for this device. Out of an abundance of caution, this complaint is being reported as an mdr since this confirmed failure has demonstrated the risk of causing serious injury to the end-user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721652-2018-00004 |
| MDR Report Key | 8204284 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-12-28 |
| Date of Report | 2018-12-28 |
| Date of Event | 2018-11-26 |
| Date Mfgr Received | 2018-12-03 |
| Device Manufacturer Date | 2013-12-09 |
| Date Added to Maude | 2018-12-28 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. STEPHEN ANDERSON |
| Manufacturer Street | 3820 WEST GREAT LAKES DRIVE |
| Manufacturer City | WEST VALLEY CITY UT 84120 |
| Manufacturer Country | US |
| Manufacturer Postal | 84120 |
| Manufacturer Phone | 8019746676 |
| Manufacturer G1 | OTTO BOCK HEALTHCARE LP |
| Manufacturer Street | 3820 WEST GREAT LAKES DRIVE |
| Manufacturer City | WEST VALLEY CITY UT 84120 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84120 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OTTO BOCK AXTION? PROSTHETIC FOOT |
| Generic Name | 1E56 AXTION? PROSTHETIC FOOT |
| Product Code | ISH |
| Date Received | 2018-12-28 |
| Model Number | 1E56 |
| Catalog Number | 1E56=N26-3-P/0 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTTO BOCK HEALTHCARE LP |
| Manufacturer Address | 3820 WEST GREAT LAKES DRIVE WEST VALLEY CITY UT 84120 US 84120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-28 |