MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-03-18 for OTTO BOCK AXTION? PROSTHETIC FOOT 1E56 1E56=N29-4-P/0 manufactured by Otto Bock Healthcare Lp.
[139213188]
Patient Sequence No: 1, Text Type: N, H10
[139213189]
It was reported by the end-user's facility that, "pyramid broke - cracked at the bolts. " after multiple attempts to gather additional information, the customer was non-responsive. No information is known about how the foot was used, events leading up to the failure, and if anything significant resulted after the failure occurred. The failure did occur within the intended use life of the specified foot. Out of an abundance of caution, this complaint is being reported as an mdr since the confirmed failure has historically caused serious injury to an end-user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721652-2019-00001 |
| MDR Report Key | 8430620 |
| Report Source | USER FACILITY |
| Date Received | 2019-03-18 |
| Date of Report | 2019-03-18 |
| Date Mfgr Received | 2019-02-19 |
| Device Manufacturer Date | 2017-08-14 |
| Date Added to Maude | 2019-03-18 |
| 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 | 2019-03-18 |
| Returned To Mfg | 2019-03-12 |
| Model Number | 1E56 |
| Catalog Number | 1E56=N29-4-P/0 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-03-18 |