FDA Adverse Event
Injury
Summary report: N
STEFFEE PLATE AND SCREW
MDR report key: 17965
·
Received November 23, 1994
Report
- Report Number
- MW1004129
- Event Type
- Injury
- Date Received
- November 23, 1994
- Date of Event
- July 12, 1994
- Report Date
- November 14, 1994
- Manufacturer
- ACROMED CORP.
- Product Code
- MCV
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NC, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
RPTR WAS SHOWED A U ROD. DR USED PLATES AND SCREWS. THIS DR NEVER TOLD RPTR WHAT HE DID. RPTR BECAME WORSE AFTER SURGERY. HE HAS HAD TO LEAVE HIS JOB ON DISABILITY. MEDICAL DR GIVES RPTR SOMETHING FOR PAIN. IF HE COULD NOT GET SOMETHING FOR PAIN HE COULD NOT GET OUT OF BED EACH DAY. DR TOLD RPTR HE COULD GET HIM 75-80% PAIN FREE. RPTR HAS BEEN IN THE HOSP FROM JUNE UNITL AUGUST, RPTR WAS IN AND OUT OFF HOSP 3 TIMES ABOUT 1-2 WEEKS AT THE TIME. HE HAS ULCERS FROM ALL OF THIS. THESE BACK DRS WON'T GIVE PAIN MEDICATION. THIS PAIN IS UNBEARABLE. RPTR HURTS 24 HRS A DAY. (ALSO SEE 1002692.)_
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 | * | Hospitalization| S |