MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-06-03 for PROSTHESIS - STAPES 1156603 manufactured by Medtronic Xomed Inc..
[46496371]
Information received from a sus voluntary event report; mw5061747. No additional information can be obtained. Concomitant device:? Big easy piston? , product number unknown, lot unknown. Product evaluation: analysis results not available; no devices were returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[46496372]
It was reported that the "patient had a previous staple prosthesis replaced. It had failed/broken during or after previous procedure" and required a procedure and replacement to repair. There was no reported patient impact.
Patient Sequence No: 1, Text Type: D, B5
[101833628]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2016-00172 |
| MDR Report Key | 5697481 |
| Report Source | OTHER |
| Date Received | 2016-06-03 |
| Date of Report | 2016-05-09 |
| Date of Event | 2016-03-03 |
| Date Mfgr Received | 2016-05-09 |
| Device Manufacturer Date | 2013-07-26 |
| Date Added to Maude | 2016-06-03 |
| 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 | MICHELLE ALFORD |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328197 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROSTHESIS - STAPES |
| Generic Name | REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL |
| Product Code | ETA |
| Date Received | 2016-06-03 |
| Model Number | 1156603 |
| Catalog Number | 1156603 |
| Lot Number | 0207247969 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-06-03 |