FDA Adverse Event
Injury
Summary report: N
ST360 SPINAL FIXATION SYSTEM
MDR report key: 1231843
·
Received November 11, 2008
Report
- Report Number
- 2184052-2008-00030
- Event Type
- Injury
- Date Received
- November 11, 2008
- Date of Event
- March 10, 2008
- Report Date
- October 8, 2008
- Manufacturer
- ZIMMER SPINE, INC.
- Product Code
- KWP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE REMAINS IN THE PT. PART NUMBERS AND LOT NUMBERS UNK.
Description of Event or Problem · 1
ORIGINAL SURGERY PERFORMED IN 2007, TO IMPLANT ST360 FIXATION SYSTEM. A REVISION SURGERY WAS PERFORMED THE FOLLOWING YEAR, TO RE-TIGHTEN THE SCREWS AND NUTS BECAUSE THE SCREWS LOOSENED AND THE RODS MIGRATED, CAUSING PAIN AN DISCOMFORT TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ST360 SPINAL FIXATION SYSTEM | SPINAL FIXATION SYSTEM | KWP | ZIMMER SPINE, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |