FDA Adverse Event
Malfunction
Summary report: N
S4 POLYAXIAL SCREW 6.0X40MM
MDR report key: 840000
·
Received February 22, 2007
Report
- Report Number
- 3005673311-2007-00013
- Event Type
- Malfunction
- Date Received
- February 22, 2007
- Date of Event
- November 1, 2006
- Report Date
- February 21, 2007
- Manufacturer
- AESCULAP IMPLANT SYSTEMS, INC.
- Product Code
- KWP
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALL AVAILABLE INFO HAS BEEN FORWARDED TO OUR MFR IN ANOTHER COUNTRY, FOR FURTHER ANALYSIS.
Description of Event or Problem · 1
A GRADE II SPONDYLOLISTHESIS REDUCTION AND L5 - S1 FUSION WAS PERFORMED ON PT. PT FELT A POP ONE DAY AFTER SURGERY. TWO DAYS AFTER SURGERY, RIGHT ROD APPEARED LOOSENED FROM THE SCREW HEAD AT S1. APPROX THREE MONTHS POST OP, BOTH RODS APPEAR TO BE DISCONNECTED. IT WAS REPORTED THAT THE SCREW AND SETSCREW IN TACT. NO REVISION SCHEDULED AT THIS TIME. REFERENCE: 3005673311-2007-00011, 3005673311-2007-00012, 3005673311-2007-00014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | S4 POLYAXIAL SCREW 6.0X40MM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | AESCULAP IMPLANT SYSTEMS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |