FDA Adverse Event
Malfunction
Summary report: N
AESCULAP VEGA
MDR report key: 7979423
·
Received October 17, 2018
Report
- Report Number
- MW5080669
- Event Type
- Malfunction
- Date Received
- October 17, 2018
- Manufacturer
- B. BRAUN / AESCULAP IMPLANT SYSTEMS, LLC.
- Product Code
- HTG
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
TIBIAL FAILURE TRAY SIDE. ASEPTIC LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 813739 | AESCULAP VEGA | TOTAL KNEE REPLACEMENT | HTG | B. BRAUN / AESCULAP IMPLANT SYSTEMS, LLC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |