FDA Adverse Event
Injury
Summary report: N
TI CLICK'X LOCKING CAP FOR TI 3-D HEAD
MDR report key: 1173403
·
Received September 23, 2008
Report
- Report Number
- 1719045-2008-00129
- Event Type
- Injury
- Date Received
- September 23, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 26, 2008
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- MNI
- PMA / PMN Number
- K031175
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
LOT#: THIS INFO WAS NOT PROVIDED DURING INITIAL REPORT. ADDITIONAL INFO HAS BEEN REQUESTED. NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. SYNTHES IS UNABLE TO DETERMINE A MFG DATE WITHOUT A LOT NUMBER.
Description of Event or Problem · 1
THE INNER SET SCREW ON THE TI CLICK'X LOCKING CAP DISLODGED POSTOPERATIVELY AND WAS PROTRUDING ABOVE THE CONSTRUCT FROM A PLIF PROCEDURE AT L4-L5. THE PT NOTICED A SMALL LUMP AND X-RAYS CONFIRMED PROTRUSION OF THE INNER SET SCREW. SURGEON NOTED FUSION AND THE LEFT SIDE OF THE CONSTRUCT WAS REMOVED. THE CONTRALATERAL SIDE WAS INTACT AND NOT REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TI CLICK'X LOCKING CAP FOR TI 3-D HEAD | CLICK'X LOCKING CAP | MNI | SYNTHES MONUMENT | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention | RODS| 3-D HEADS| SCREWS |