FDA Adverse Event
Injury
Summary report: N
STRYKER SPINE XIA 4.5 TITANIUM ROD
MDR report key: 1052888
·
Received May 28, 2008
Report
- Report Number
- MW5007050
- Event Type
- Injury
- Date Received
- May 28, 2008
- Report Date
- January 23, 2008
- Manufacturer
- STRYKER SPINE
- Product Code
- JDN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
2008, PROCEDURE GRADE II SPONDYLOLISTHESIS WITH FRACTURE OF BILATERAL 4.5 TI RODS. REMOVAL OF FRACTURED RODS. RE- INSTRUMENTATION WITH VITALLIUM RODS AND 2 PROXIMAL S1 SCREWS. ILIAC CREST BONE GRAFTING. SPINAL STENOSIS DECOMPRESSION BY NEUROSURGERY. ROD IN QUESTION WAS A STRYKER XIA 4.5MM BY 200 MM LENGTH. REF # 48733200, LOT # EMF WAS CUT IN TWO PIECES AND IMPLANTED IN PT. BOTH PIECES OF ROD BROKE. THIS ROD IS MADE OF TITANIUM. DIAGNOSIS OR REASON FOR USE: SPONDYLOLISTHESIS, L5-S1 GRADE 2 SPINAL DISEASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRYKER SPINE XIA 4.5 TITANIUM ROD | 4.5 TITANIUM SPINAL ROD | JDN | STRYKER SPINE | REF 48733200 | EMF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR | Required Intervention |