FDA Adverse Event
Death
Summary report: N
CEMENT PALACOS MV ZIRCONIUM DIOXIDE ST LF
MDR report key: 17535114
·
Received August 12, 2023
Report
- Report Number
- MW5142013
- Event Type
- Death
- Date Received
- August 12, 2023
- Date of Event
- August 5, 2022
- Report Date
- August 24, 2022
- Manufacturer
- STRYKER HOWMEDICA OSTEONICS CORP
- Product Code
- LOD
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
CLINICAL ADVERSE EVENT RECEIVED FOR DEATH FROM AUTO ACCIDENT EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 729065 | CEMENT PALACOS MV ZIRCONIUM DIOXIDE ST LF | BONE CEMENT | LOD | STRYKER HOWMEDICA OSTEONICS CORP | 92744744 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |