FDA Adverse Event
Other
Summary report: N
TRINICA ANTERIOR CERVICAL PLATE SYSTEM
MDR report key: 522447
·
Received April 27, 2004
Report
- Report Number
- 2184052-2004-00006
- Event Type
- Other
- Date Received
- April 27, 2004
- Date of Event
- March 26, 2004
- Report Date
- April 27, 2004
- Manufacturer
- ZIMMER SPINE
- Product Code
- HWX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT UNDERWENT CERVICAL STABILIZATION SURGERY IN 2004 AT C4/C5-C6/C7. A THREE LEVEL TINICA CERVICAL PLATE WAS IMPLANTED AND HELD INTO PLACE WITH FIVE (FIVE) 12MM TRINICA VARIABLE ANGLE SCREWS AND 2 TRINICA FIXED ANGLE SCREWS. THE PHYSICIAN IN THIS CASE USED A TRINICA BONE TAP, (LOT # P020877) TO CREATE AN ENTRY PATH INTO THE VERTEBRAL BODY (C5) WHEN THE TIP OF THE BONE TAP BROKE OFF INSIDE THE VERTEBRAL BODY. THE BROKEN PIECE WAS NOT REMOVED AND SUBSEQUENTLY, NO SCREW WAS IMPLANTED IN THAT LOCATION. AS OF 4/2004 THERE HAS BEEN NO REPORT OF PT DISCOMFORT/PAIN/PROBLEM AS A RESULT OF THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRINICA ANTERIOR CERVICAL PLATE SYSTEM | BONE TAP | HWX | ZIMMER SPINE | NA | P020877 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |