FDA Adverse Event
Injury
Summary report: N
TI CLICK'X LOCKING CAP FOR THE TI 3-D HEAD
MDR report key: 1023287
·
Received April 1, 2008
Report
- Report Number
- 1719045-2008-00029
- Event Type
- Injury
- Date Received
- April 1, 2008
- Report Date
- March 5, 2008
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- MNH
- PMA / PMN Number
- K000450
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
A ROD, IMPLANTED DURING A ONE LEVEL LUMBAR PROCEDURE, WAS NOTED ON 2-WEEK FOLLOW-UP X-RAY TO HAVE MIGRATED. PATIENT WAS RETURNED TO THE OR FOR REMOVAL OF OLD HARDWARE AND PLACEMENT OF NEW HARDWARE. THE L3 LOCKING CAP WAS NOTED TO HAVE A SEPARATION IN THE SADDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TI CLICK'X LOCKING CAP FOR THE TI 3-D HEAD | CLICK'X LOCKING CAP | MNH | SYNTHES MONUMENT | NA | 1800517 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention | RODS| 3-D HEADS| SCREWS| BONE GRAFT |