MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-02-20 for OTTO BOCK AXTION? PROSTHETIC FOOT manufactured by Otto Bock Healthcare Lp.
[67821282]
Device not returned. Eval. From photos.
Patient Sequence No: 1, Text Type: N, H10
[67821283]
The end-user was using the axtion foot walking on level ground when the pyramid adapter broke in half. No fall or injury occured during this event. Although the customer's foot was beyond the warranty period, he felt inclined to report the foot's failure. Out of an abundance of caution, this complaint will be reported as an mdr since the confirmed device failure is known to have the potential to cause serious injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721652-2017-00003 |
| MDR Report Key | 6343285 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-20 |
| Date of Report | 2017-02-20 |
| Date of Event | 2016-11-22 |
| Date Mfgr Received | 2016-11-22 |
| Date Added to Maude | 2017-02-20 |
| 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 | SALT LAKE CITY 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 | OT |
| 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 | 2017-02-20 |
| 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 | 2017-02-20 |