MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-02 for STEM ULNAR CUSTOM LENGTH 103 SMALL manufactured by Tornier, Inc..
[140602363]
Elbow hardware failure requiring replacement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8472798 |
| MDR Report Key | 8472798 |
| Date Received | 2019-04-02 |
| Date of Report | 2019-02-13 |
| Date of Event | 2019-01-25 |
| Report Date | 2019-02-13 |
| Date Reported to FDA | 2019-02-13 |
| Date Reported to Mfgr | 2019-04-02 |
| Date Added to Maude | 2019-04-02 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STEM ULNAR CUSTOM LENGTH 103 SMALL |
| Generic Name | PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED |
| Product Code | JDB |
| Date Received | 2019-04-02 |
| Device Availability | Y |
| Device Age | 7 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORNIER, INC. |
| Manufacturer Address | 10801 NESBITT AVENUE SOUTH BLOOMINGTON MN 55437 US 55437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-02 |