FDA Adverse Event
Injury
Summary report: N
STEFFE PEDICLE SCREW
MDR report key: 22409
·
Received June 13, 1995
Report
- Report Number
- MW1006212
- Event Type
- Injury
- Date Received
- June 13, 1995
- Date of Event
- December 1, 1990
- Manufacturer
- MICRO MED, INC.
- Product Code
- MCV
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
THIS LETTER IS TO INFORM YOU THAT THIS MED WATCH FORM WAS RETURNED TO MICRO-MED, INC. IN ERROR. MICRO-MED, IS NOT A MFR OF PEDICLE SCREWS; AS DESCRIBED IN THIS REPORT. I CANNOT OFFER AN EXPLANATION AS TO HOW MICRO-MED'S NAME APPEARED ON THIS FORM, BUT I CAN ASSURE YOU THAT WE DO NOT MFG THIS ITEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEFFE PEDICLE SCREW Implant | PEDICLE SCREW | MCV | MICRO MED, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Disability |