FDA Adverse Event
Injury
Summary report: N
MESA PEDICLE SCREW
MDR report key: 2123094
·
Received September 5, 2008
Report
- Report Number
- 3004774118-2008-00005
- Event Type
- Injury
- Date Received
- September 5, 2008
- Date of Event
- June 26, 2008
- Report Date
- July 30, 2008
- Manufacturer
- K2M, INC
- Product Code
- MNI
- PMA / PMN Number
- K052398
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICES WERE ANALYZED AND FUNCTIONALLY TESTED AND NO DEFECTS OR GROSS DAMAGE IDENTIFIED THAT WOULD HAVE CAUSED THE COMPONENTS TO DIS-ASSOCIATE. OTHER DEVICES FROM THE SAME MFG LOT WERE ANALYZED AND TESTED. THE MFG HISTORY OF THE DEVICES HAS BEEN REVIEWED. NO CONCLUSIONS CAN BE REACHED AT THIS TIME. THIS IS A RARE OCCURRENCE AND IS BEING MONITORED.
Description of Event or Problem · 1
F/U X-RAYS SHOWED THE ROD DISASSOCIATED FROM THE RIGHT L3 PEDICLE SCREW. REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE SCREW AND ROD. DURING REVISION SURGERY, IT WAS CONFIRMED THAT THE ROD HAVE DIS-ENGAGED FROM THE HEAD OF THE PEDICLE SCREW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MESA PEDICLE SCREW | PEDICLE SCREW | MNI | K2M, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |