FDA Adverse Event
Summary report: N
STEFFEE PLATE AND SCREW
MDR report key: 21445
·
Received April 24, 1995
Report
- Report Number
- MW1005722
- Date Received
- April 24, 1995
- Date of Event
- May 1, 1993
- Report Date
- March 7, 1995
- Manufacturer
- ACROMED CORP.
- Product Code
- MCV
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
RPTR HAD SURGERY 2 TIMES IN 1986, IN JAN AND JULY, BECAUSE OF LOWER BACK AND LEG PAIN. THE RUPTURED DISC WAS REMOVED 2 TIMES. THE PAIN CONTINUED AND BECAME WORSE. RPTR'S DR REFERRED HER TO 2 OTHER DOCTORS IN 1989. IN 11/89, SHE BECAME WORSE. IT WAS AT THAT TIME THE DRS TOLD HER ABOUT PUTTING A METAL PLATE WITH SCREWS TO PERFORM THE FIXATION. HER PAIN WAS SO BAD SHE COULD HARDLY STAND ANY ACTIVITY. IN 1993, THE PLATES AND SCREWS WERE REMOVED BECAUSE SHE WAS HAVING SO MUCH PAIN. THE PAIN HASN'T GOTTEN ANY BETTER AND AT TIMES IT IS WORSE. SHE BECAME VERY DEPRESSED AND HAD TO GO TO THE HOSP IN 3/94.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEFFEE PLATE AND SCREW Implant | PLATE AND SCREW | MCV | ACROMED CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR |