FDA Adverse Event
Injury
Summary report: N
S4 SET SCREW NEW VERSION
MDR report key: 852650
·
Received May 10, 2007
Report
- Report Number
- 3005673311-2007-00020
- Event Type
- Injury
- Date Received
- May 10, 2007
- Date of Event
- April 9, 2007
- Report Date
- May 9, 2007
- Manufacturer
- AESCULAP IMPLANT SYSTEMS, INC.
- Product Code
- KWP
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLES AND ALL AVAILABLE INFORMATION HAVE BEEN FORWARDED TO OUR MANUFACTURER FOR FURTHER ANALYSIS.
Description of Event or Problem · 1
SINGLE LEVEL, L3/4 SPONDYLOLISTHESIS REDUCTION. APPLIED 6-8 NM OF PRESSURE AND THREADS CAME APART AND STRIPPED OUT WHEN PLACING SEVERAL SETSCREWS. SURGEON REMOVED ALL AESCULAP PARTS AND REPLACED WITH ANOTHER MANUFACTURERS. PROLONGED SURGERY APPROXIMATELY 1 1/2 HOURS. SHARDS OF METAL CAME OFF SETSCREWS. SITE WAS IRRIGATED/SUCTIONED TO REMOVE. SURGEON FELT HE RETRIEVED EVERYTHING. PERFORMED X-RAY. PERMANENT COPIES OF X-RAYS NOT MADE.
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 | 51272865 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |