FDA Adverse Event
Injury
Summary report: N
KNODT ROD
MDR report key: 18369
·
Received December 9, 1994
Report
- Report Number
- MW1004414
- Event Type
- Injury
- Date Received
- December 9, 1994
- Date of Event
- June 28, 1989
- Report Date
- November 14, 1994
- Manufacturer
- ZIMMER, INC.
- Product Code
- JDN
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
L3-4 FUSION WITH RODS, 6/28/89. ON 1/90 NUMBNESS AND PAIN BEGAN AGAIN. PAIN IS NOW WORSE THEN BEFORE SRGERY. LEFT LEG CAUSES RPTR TO FALL , PAIN SO SEVERE RPTR CAN'T SLEEP DAY OR NIGHT. SHE CAN'T DO HOUSEWORK OR CARE FOR FAMILY. SHE HAS TO HAVE HELP TO DO ALL THINGS. SHE CAN'T EVEN DRESS HERSELF. RPTR HAS DIARRHEA CONSTANTLY, FALLS FROM LEG GIVING AWAY, NEVER GO ANY WHERE BY HERSELF. WHOLE BODY BURSTS, JOINTS SWELL, CAN'T PUT CHIN TO CHEST FOR PAIN IN BACK, CANT SIT, FELL ON RIGHT HAND, BENT FINGERS BACK. NOW SHE HAS CORPAL TUNNEL IN RIGHT WRIST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KNODT ROD Implant | ROD | JDN | ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Disability |