MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-22 for STEM ULNAR CUSTOM SMALL LEFT DXY002 manufactured by Tornier S.a.s..
[184082466]
This is the final report submitted regarding this surgical event and medical device (please refer to medwatch report sent by hospital (b)(6) (b)(4)).
Patient Sequence No: 1, Text Type: N, H10
[184082467]
Elbow hardware failure requiring replacement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3000931034-2019-00074 |
| MDR Report Key | 9742709 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-22 |
| Date of Report | 2019-04-25 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2019-04-25 |
| Device Manufacturer Date | 2009-03-18 |
| Date Added to Maude | 2020-02-22 |
| 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 | MS. MAUD ANDRIOLLO |
| Manufacturer Street | 161 RUE LAVOISIER |
| Manufacturer City | MONTBONNOT SAINT-MARTIN, 38330 |
| Manufacturer Country | FR |
| Manufacturer Postal | 38330 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STEM ULNAR CUSTOM |
| Generic Name | PROSTHESIS, ELBOW, SEMI-CONSTRAINED CEMENTED |
| Product Code | JDB |
| Date Received | 2020-02-22 |
| Model Number | SMALL LEFT |
| Catalog Number | DXY002 |
| Lot Number | 002 |
| Device Expiration Date | 2014-03-18 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORNIER S.A.S. |
| Manufacturer Address | 161 RUE LAVOISIER MONTBONNOT SAINT-MARTIN, 38330 FR 38330 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-22 |