D
Patient 1
THE BOTTOM PORTION OF STRYKER REVOLUTION CEMENT MIXING SYSTEM BROKE OFF DURING THE MIXING OF CEMENT. FDA SAFETY REPORT ID # (B)(4).
MAUDE MDR 9676977
- MDR report key
- 9676977
- Report number
- MW5092804
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-02-01
- Date received
- 2020-02-05
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- P
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | REVOLUTION CEMENT MIXING SYSTEM | MIXER, CEMENT, FOR CLINICAL USE | STRYKER INSTRUMENTS | JDZ | 0606-563-000 | 0606-563-000 | 19253012 | I | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-02-05 | 0 |