FDA Adverse Event
Injury
Summary report: N
4.0MM OPEN CONNECTOR CLOSURE TOP
MDR report key: 1033981
·
Received April 24, 2008
Report
- Report Number
- 1649384-2008-00229
- Event Type
- Injury
- Date Received
- April 24, 2008
- Date of Event
- March 25, 2008
- Report Date
- April 24, 2008
- Manufacturer
- ABBOTT SPINE
- Product Code
- HXX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REQUEST HAS BEEN MADE TO OBTAIN THE PRODUCT. EVALUATION IS PENDING UPON THE RETURN OF THE PRODUCT.
Description of Event or Problem · 1
IN 2008, THE SALES REPRESENTATIVE REPORTED THAT DURING SURGERY, THE SURGEON WAS ATTEMPTING TO LOCK DOWN THE CLOSURE TOP WHEN THE DRIVER STRIPPED. ADDITIONAL INFORMATION RECEIVED, APRIL 21, 2008, VIA TELEPHONE. THE SALES REP REPORTED THAT DURING SURGERY, THE SURGEON WAS ATTEMPTING TO IMPLANT THE FIRST CLOSURE TOP AND THE DRIVER STRIPPED THE CLOSURE TOP. THE SURGEON INTERVENED AND EXPLANTED THE CLOSURE TOP AND REPLACED IT WITH ANOTHER. AT THAT TIME, THE SURGEON CHANGED OUT THE DRIVER TO THE SECOND DRIVER AND COMPLETED THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4.0MM OPEN CONNECTOR CLOSURE TOP | NEXLINK | HXX | ABBOTT SPINE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |