FDA Adverse Event
Injury
Summary report: N
CONSERVE TOTAL A-CLASS HEAD
MDR report key: 1456855
·
Received August 27, 2009
Report
- Report Number
- 1043534-2009-00269
- Event Type
- Injury
- Date Received
- August 27, 2009
- Date of Event
- August 4, 2009
- Report Date
- August 4, 2009
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- JDL
- PMA / PMN Number
- K051348
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. PRODUCT HAS NOT BEEN RETURNED. THE EVENT DEVICE CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2009-000267 AND 000268.
Description of Event or Problem · 1
ALLEGEDLY REMOVED DURING REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSERVE TOTAL A-CLASS HEAD | JDL | WRIGHT MEDICAL TECHNOLOGY, INC. | NA | 046330370 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization| R |