FDA Adverse Event
Injury
Summary report: N
EXPEDIUM SINGLE INNER SETSCREW
MDR report key: 2191060
·
Received July 29, 2011
Report
- Report Number
- 1526439-2011-00132
- Event Type
- Injury
- Date Received
- July 29, 2011
- Manufacturer
- DEPUY SPINE INC.
- Product Code
- MNH
- PMA / PMN Number
- K062174
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE HAS NOT YET BEEN RETURNED FOR EVAL. A DEFINITIVE CAUSE OF THE EVENT CANNOT BE DETERMINED AT THIS TIME. CARE MUST BE TAKEN TO ENSURE THAT THE CONSTRUCT FULLY TIGHTENED AND ASSEMBLED PROPERLY. CONSTRUCT LOOSENING IS LISTED AS A POSSIBLE ADVERSE OUTCOME IN THE INSTRUCTIONS-FOR-USE (IFU) SUPPLIED WITH THE DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SET SCREW LOOSENED AFTER SURGERY. ON (B)(6) 2010, L2-L5 INSTRUMENTATION WAS DONE WITH EXPEDIUM SYSTEM. THREE TO FOUR MONTHS AFTER THE SURGERY, IT WAS FOUND THAT THE SET SCREW IN L5 CAME FREE. A REVISION PROCEDURE WAS PERFORMED. AS A RESULT OF THIS ADVERSE OUTCOME AN MDR IS FILED TO DOCUMENT THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXPEDIUM SINGLE INNER SETSCREW | SPINAL FIXATION DEVICE | MNH | DEPUY SPINE INC. | NA | ALFC35 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |