FDA Adverse Event
Injury
Summary report: N
TI 3-D HEAD FOR TI CLICK'X SCREWS
MDR report key: 2150712
·
Received June 24, 2011
Report
- Report Number
- 1719045-2011-00321
- Event Type
- Injury
- Date Received
- June 24, 2011
- Report Date
- May 25, 2011
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- NKB
- PMA / PMN Number
- K082572
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED. DEVICE WAS NOT EXPLANTED. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Description of Event or Problem · 1
PATIENT STATUS POST POSTERIOR LUMBAR FUSION, IMPLANTED WITH RODS, SCREWS AND LOCKING CAPS AT L3-L5 IN 2002. PATIENT BECOME MYLEOPATHIC AND SURGEON NOTED NERVE ROOT AT L4 WAS INFLAMED AND ADJACENT LEVEL DISEASE AT L2. PATIENT RETURNED TO OPERATING ROOM. RODS AND LOCKING CAP WERE REMOVED, SCREWS ADDED TO L2, NEW RODS AND CAPS PLACED, SURGERY COMPLETED. THIS IS THE 17TH OF 20 REPORTS SUBMITTED ON THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TI 3-D HEAD FOR TI CLICK'X SCREWS | 3-D HEAD | NKB | SYNTHES MONUMENT | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention | 3-D HEADS| SCREWS| LOCKING CAPS| RODS |