FDA Adverse Event
Injury
Summary report: N
REFORM 7.5 X 45MM POLYAXIAL PEDICLE SCREW
MDR report key: 3962612
·
Received July 15, 2014
Report
- Report Number
- 3005739886-2014-00033
- Event Type
- Injury
- Date Received
- July 15, 2014
- Date of Event
- June 16, 2014
- Report Date
- June 16, 2014
- Manufacturer
- PRECISION SPINE, INC.
- Product Code
- MNH
- PMA / PMN Number
- K121172
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL IMPLANTATION TO FUSE L2-S1 ON (B)(6) 2013. REVISION WAS PERFORMED ON (B)(6) 2014 DURING WHICH TWO BROKEN REFORM POLYAXIAL SCREWS WERE REMOVED. THE TWO FRACTURED SCREWS WERE LOCATED IN THE SACRUM AND WERE BOTH 7.5MM X 45MM REFORM POLYAXIAL PEDICLE SCREWS. (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 411807 | REFORM 7.5 X 45MM POLYAXIAL PEDICLE SCREW | MNH, MNI | MNH | PRECISION SPINE, INC. | 0105RM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Hospitalization| R |