MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-26 for UNIVERSAL TITANIUM PROSTHESIS REF 1150001 manufactured by Medtronic Xomed.
[5134413]
Universal titanium prosthesis, cam head, with flex h/a titanium shoe broke while being implanted in the pt' ear. A small metal piece was lost in the middle ear and the dr was unable to visualize it and said, "i cannot find it and if i go digging around i can cause more damage. " so the decision was made not to retrieve it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4321044 |
| MDR Report Key | 4321044 |
| Date Received | 2014-11-26 |
| Date of Report | 2014-11-25 |
| Date of Event | 2014-09-29 |
| Date Facility Aware | 2014-09-29 |
| Report Date | 2014-11-25 |
| Date Reported to FDA | 2014-11-25 |
| Date Reported to Mfgr | 2014-11-25 |
| Date Added to Maude | 2014-12-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL TITANIUM PROSTHESIS |
| Generic Name | UNIVERSAL TITANIUM PROSTHESIS |
| Product Code | ETA |
| Date Received | 2014-11-26 |
| Model Number | REF 1150001 |
| Lot Number | 0207296386 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED |
| Manufacturer Address | 4102 SOUTHPOINT BLVD JACKSONVILLE FL 32216092 US 32216 0929 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-26 |