FDA Adverse Event
Injury
Summary report: N
EXPEDIUM 5.50 POLYAXIAL SCREW 5.00X40MM, SS
MDR report key: 2080639
·
Received April 25, 2011
Report
- Report Number
- 1526439-2011-00070
- Event Type
- Injury
- Date Received
- April 25, 2011
- Date of Event
- March 30, 2011
- Manufacturer
- DEPUY SPINE, INC.
- Product Code
- KWP
- PMA / PMN Number
- K041119
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE POLYAXIAL SCREW HAS BEEN RETURNED FOR EVAL. A F/U MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVAL.
Description of Event or Problem · 1
CONTACT REPORTS THREE EXPEDIUM PEDICLE SCREWS WERE EXPLANTED DUE TO DEVICE BREAKAGE. THE DEVICES HAD BEEN IMPLANTED FOR MORE THAN A YEAR. PSEUDARTHROSIS WAS CONFIRMED AS TIME OF REVISION SURGERY. SEE MFG MEDWATCH REPORT NOS. 1526439-2011-00068 AND 1526439-2011-00069 FOR THE OTHER TWO PEDICLE SCREWS THAT WERE INVOLVED IN THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXPEDIUM 5.50 POLYAXIAL SCREW 5.00X40MM, SS | SPINAL FIXATION DEVICE | KWP | DEPUY SPINE, INC. | NA | RE058317 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |