MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-17 for AESCULAP VEGA manufactured by B. Braun / Aesculap Implant Systems, Llc..
[124500595]
Tibial failure tray side. Aseptic loosening.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080669 |
| MDR Report Key | 7979423 |
| Date Received | 2018-10-17 |
| Date Added to Maude | 2018-10-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AESCULAP VEGA |
| Generic Name | TOTAL KNEE REPLACEMENT |
| Product Code | HTG |
| Date Received | 2018-10-17 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN / AESCULAP IMPLANT SYSTEMS, LLC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-17 |