FDA Adverse Event
Death
Summary report: N
*
MDR report key: 319894
·
Received March 8, 2001
Report
- Report Number
- 1811755-2001-00005
- Event Type
- Death
- Date Received
- March 8, 2001
- Report Date
- February 20, 2001
- Manufacturer
- STRYKER INSTRUMENTS
- Product Code
- HAB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
DURING SURGERY BLACK FLUID LEAKED FROM THE TIP OF THE SAGITTAL SAW ONTO THE BONE. THE SURGEON IRRIGATED THE SITE WITH AN ANTIBIOTIC SOLUTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 9879 | * | * | HAB | STRYKER INSTRUMENTS | 2296-034-000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |