FDA Adverse Event
Summary report: N
SULZER SPINE-TECH
MDR report key: 458107
·
Received April 10, 2003
Report
- Report Number
- MW4003501
- Date Received
- April 10, 2003
- Date of Event
- January 24, 2000
- Report Date
- April 10, 2003
- Manufacturer
- SULZER SPINE TECH
- Product Code
- MCV
- Report Source
- Voluntary report
- Reporter Location
- OH, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
PT REPORTED THAT IN 2000, THEY REQUIRED SURGICAL IMPLANTATION OF A SULZER SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM, A SPINAL FUSION DEVICE (SULZER CATALOG #7220-65-35-05). WITHIN 90 DAYS AFTER THEIR SURGERY, THEY EXPERIENCED SEVERE LEG PAINS DOWN TO THEIR HEEL. THIS PAIN WAS CONTINUOUS UNTIL THE DEVICE WAS SURGICALLY REMOVED IN 2002. THE DOCTOR WHO REMOVED THE DEVICE FROM THEIR BACK INFORMED PT THAT ONE OF THE FOUR PEDICLE SCREWS THAT HOLD THE UNIT IN PLACE HAD FAILED, WHICH RESULTED IN THEIR PAIN. THE COMPLAINANT SEARCHED THE FDA WEBSITE AND FOUND MULTIPLE COMPLAINTS FOR THIS DEVICE, AND ALSO CONTACTED THE MFR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SULZER SPINE-TECH | SILHOUETTE SPINAL FIXATION SYSTEM (SPINAL FUSION DEVICE) | MCV | SULZER SPINE TECH | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |