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 2018-11-14 for OTTO BOCK AXTION? PROSTHETIC FOOT 1E56 1E56=N29-5-P/0 manufactured by Otto Bock Healthcare Lp.
[129188015]
Submission was originally attempted on 11/13/2018. It was discovered on 11/13/2018 that the original submission was not accepted due use of an incorrect icsr version. Icsr r2 is now required. I re-installed esubmitter in hopes the problem is resolved and my submission will be accepted. The cdrh emdr help desk suggested the re-installing of the esubmitter would resolve this issue. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[129188016]
The end-user was walking into a movie theatre and heard a crack. Immediately the end-user realized the pyramid adapter had cracked causing the foot to become disconnected from their pylon. The end-user avoided falling and was able to get back to his home safely. He used a back up foot until his axtion foot was replaced. No fall or injury resulted. All information reported by the customer and end-user indicates 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 | 1721652-2018-00003 |
| MDR Report Key | 8071584 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-11-14 |
| Date of Report | 2018-11-13 |
| Date of Event | 2018-10-15 |
| Date Mfgr Received | 2018-10-16 |
| Device Manufacturer Date | 2016-08-08 |
| Date Added to Maude | 2018-11-14 |
| 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 | 2018-11-14 |
| Returned To Mfg | 2018-11-12 |
| Model Number | 1E56 |
| Catalog Number | 1E56=N29-5-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 | 2018-11-14 |