FDA Adverse Event
Malfunction
Summary report: N
TRAXIS VUE
MDR report key: 686928
·
Received March 8, 2006
Report
- Report Number
- 1649384-2006-00021
- Event Type
- Malfunction
- Date Received
- March 8, 2006
- Report Date
- March 8, 2006
- Manufacturer
- ABBOTT SPINE
- Product Code
- KWQ
- Removal / Correction Number
- RCR#1649384-11/2/05-0001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A TRAXIS VUE IMPLANTS FROM THE DEFECTIVE LOT MAY HAVE BEEN IMPLANTED DURING 2 SEPARATE SURGERIES, (MDR#16493842005-00072 AND 1649384-2005-00073). COMPLETE INFO REGARDING THE TWO CASES WAS NOT AVAILABLE AT THE TIME THE MDRS WERE REPORTED AND ACTUAL IMPLANTATION COULD NOT BE CONFIRMED. ON 2/10/2006, THE X-RAYS AND OPERATING ROOM DOCUMENTATION WAS RECEIVED. THIS DOCUMENTATION REVEALED THAT A TOTAL OF 3 PTS WERE IMPLANTED WITH THE TRAXIS VUE PEEK IMPLANT, LOT NUMBER 2010292. ONE IMPLANT WAS USED PER PT FROM THIS LOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRAXIS VUE | TRAXIS VUE PEEK | KWQ | ABBOTT SPINE | NI | 2010292 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |