FDA Adverse Event
Other
Summary report: N
ST360 SPINAL FIXATION SYSTEM
MDR report key: 543800
·
Received September 16, 2004
Report
- Report Number
- 2184052-2004-00015
- Event Type
- Other
- Date Received
- September 16, 2004
- Date of Event
- September 1, 2004
- Report Date
- September 16, 2004
- Manufacturer
- ZIMMER SPINE, INC.
- Product Code
- MCV
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ORIGINAL SURGERY WAS 2004; POST-OP X-RAY TAKEN. APPROXIMATELY 3-4 WEEKS POST-OP PT ATTEMPTED TO LIFT A 50 LB TOOL CHEST AND FELT SOMETHING POP. PT X-RAYS WERE TAKEN AND CONFIRMED A BROKEN SCREW AT S1, 6.5X40MM PEDICLE SCREW. REVISION SURGERY SCHEDULED 4 MONTHS LATER AND WAS COMPLETED TO REMOVE BROKEN SCREW AT S1; EMBEDDED BROKEN PORTION OF SCREW REMAINS IN THE PT. 7.5X30MM SCREW WAS IMPLANTED AT S1 NEXT TO BROKEN SCREW AND ATTACHED TO THE EXISTING CONSTRUCT. BONE GROWTH WAS OCCURRING, HOWEVER, PT WAS NOT COMPLETELY FUSED. DATES OF X-RAYS INCLUDE AUG-2004, PRE REVISION SURGERY, AND 2004, POST REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ST360 SPINAL FIXATION SYSTEM | ST360 PEDICLE SCREW | MCV | ZIMMER SPINE, INC. | NA | P030023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Other |