FDA Adverse Event
Injury
Summary report: N
S4 SET SCREW NEW VERSION
MDR report key: 858864
·
Received May 30, 2007
Report
- Report Number
- 3005673311-2007-00023
- Event Type
- Injury
- Date Received
- May 30, 2007
- Date of Event
- May 14, 2007
- Report Date
- May 29, 2007
- Manufacturer
- AESCULAP IMPLANT SYSTEMS, INC.
- Product Code
- KWP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLES AND ALL AVAILABLE INFORMATION HAVE BEEN FORWARDED TO OUR MANUFACTURER, IN ANOTHER COUNTRY, FOR FURTHER ANALYSIS.
Description of Event or Problem · 1
ORIGINAL SURGERY PERFORMED IN 2007, T11-L5 FUSION. SETSCREW CAME OUT OF TULIP OF SCREW AT L5/RIGHT. PERFORMED REVISION SURGERY FOUR MONTHS LATER. RE-OPERATION TO RETRIEVE AND REPLACE SETSCREW. MALE, BHK, ADMIT DATE: 2007, MODERATE OSTEOPOROSIS; PATIENT NOTED STEPPED IN HOLE AND FELT HE JARRED HIS BACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | S4 SET SCREW NEW VERSION | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | AESCULAP IMPLANT SYSTEMS, INC. | NA | 51353060 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |