FDA Adverse Event
Injury
Summary report: N
OP80 SAGITTAL SAW
MDR report key: 91373
·
Received May 1, 1997
Report
- Report Number
- 1811755-1997-00039
- Event Type
- Injury
- Date Received
- May 1, 1997
- Date of Event
- April 11, 1997
- Manufacturer
- STRYKER INSTRUMENTS
- Product Code
- KFK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE SAW WAS VERY NOISY. DURING SURGERY, THE SAW WENT THROUGH THE TISSUE OF THE HEART. DR. WAS ABLE TO COMPLETE THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OP80 SAGITTAL SAW | SAW | KFK | STRYKER INSTRUMENTS | 0297-088-000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |