FDA Adverse Event
Other
Summary report: N
MERCURY POLYAXIAL SCREW
MDR report key: 2987994
·
Received December 17, 2012
Report
- Report Number
- 3004893332-2012-00005
- Event Type
- Other
- Date Received
- December 17, 2012
- Date of Event
- November 14, 2012
- Report Date
- December 10, 2012
- Manufacturer
- SPINAL ELEMENTS, INC.
- Product Code
- KWQ
- PMA / PMN Number
- K071914
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE REPRESENTATIVE REPORTED, IN HER INITIAL CALL TO SPINAL ELEMENTS, THAT THE DOCTOR SAID THE REASON FOR THE REVISION WAS LOOSE SCREWS. HOWEVER, I SPOKE WITH THE REPRESENTATIVE PRESENT AT THE REVISION SURGERY AND SHE INDICATED THAT THERE WAS NO FAILURE WITH OUR PRODUCTS. TWO LEVELS HAD FUSED A THIRD LEVEL HAD NOT, WHICH IS PERHAPS WHY THE REVISION WAS MADE. THE HARDWARE IS NOT BEING RETURNED FOR SPINAL ELEMENTS TO MAKE AN INSPECTION.
Description of Event or Problem · 1
UNKNOWN REASON FOR REVISION SURGERY. REPRESENTATIVE REPORTED THAT SHE COULD NOT ASCERTAIN ANY FAILURE OF THE PRODUCT. NONETHELESS, WE ARE FILING THIS REPORT OUT OF AN ABUNDANCE OF CAUTION. WE HAVE NO INFORMATION ABOUT THE PATIENT OR CIRCUMSTANCES WHICH CAUSED THE REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MERCURY POLYAXIAL SCREW | POLYAXIAL SCREW | KWQ | SPINAL ELEMENTS, INC. | 62075-040, 62075-045 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |