FDA Adverse Event
Injury
Summary report: N
CONSERVE(R) TOTAL HEAD
MDR report key: 4093661
·
Received September 16, 2014
Report
- Report Number
- 3010536692-2014-01369
- Event Type
- Injury
- Date Received
- September 16, 2014
- Date of Event
- June 2, 2014
- Report Date
- August 20, 2014
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- KWA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ALLEGEDLY THE PATIENT WAS REVISED DUE TO MOM COMPLICATIONS (RIGHT).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 573340 | CONSERVE(R) TOTAL HEAD | HIP COMPONENT | KWA | MICROPORT ORTHOPEDICS INC. | 085260579 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |