FDA Adverse Event
Injury
Summary report: N
SILHOUETTE PEDICLE SCREW
MDR report key: 1406130
·
Received June 19, 2009
Report
- Report Number
- 2184052-2009-00057
- Event Type
- Injury
- Date Received
- June 19, 2009
- Date of Event
- May 19, 2009
- Report Date
- May 20, 2009
- Manufacturer
- ZIMMER SPINE, INC.
- Product Code
- MCV
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO PART NUMBER OR LOT NUMBER PROVIDED, DEVICE WAS NOT RETURNED.
Description of Event or Problem · 1
EIGHT YEARS AFTER ORIGINAL SURGERY, IT WAS REPORTED THAT THE PT WAS SEEN DUE TO THE VERTEBRAL BODY AT L5 COLLAPSING AND BREAKING THE SCREW. THIS RESULTED IN KYPHOSIS, CAUSING THE SCREWHEADS AT L4 TO PROTRUDE WHICH RESULTED IN PAIN AND MYELITIS. ALL THE HARDWARE WAS REMOVED, BUT NOT REPLACED. NO FURTHER COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILHOUETTE PEDICLE SCREW | PEDICLE SCREW | MCV | ZIMMER SPINE, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Hospitalization| R |