FDA Adverse Event
Injury
Summary report: N
ICON MODULAR SPINAL FIXATION SYSTEM
MDR report key: 1243689
·
Received November 25, 2008
Report
- Report Number
- 1225457-2008-00027
- Event Type
- Injury
- Date Received
- November 25, 2008
- Report Date
- October 24, 2008
- Manufacturer
- BLACKSTONE MEDICAL, INC.
- Product Code
- MNI
- PMA / PMN Number
- K050892
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION METHOD AND EVALUATION RESULTS - DEVICE WAS NOT RETURNED TO MANUFACTURER; NO EVALUATION COULD BE PERFORMED.
Description of Event or Problem · 1
AN L3-L5 MIS TLIF PROCEDURE WAS PERFORMED IN 2008. APPROXIMATELY ONE MONTH LATER, IT WAS NOTED THE ROD ON THE LEFT SIDE HAD PULLED OUT OF THE MULTI-AXIAL SCREW BODY AND ONE OF THE SET SCREWS ON THE RIGHT SIDE HAD BACKED OUT OF THE RIGHT SIDE. A REVISION SURGERY WAS PERFORMED AT ABOUT ONE MONTH LATER TO REPLACE THE ENTIRE SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ICON MODULAR SPINAL FIXATION SYSTEM | SPINAL PEDICLE FIXATION | MNI | BLACKSTONE MEDICAL, INC. | 54-2001/54-7000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |