FDA Adverse Event
Malfunction
Summary report: N
ASSEMBLY, SCREWDRIVER SLEEVE, VERTEVIEW
MDR report key: 1559073
·
Received December 4, 2009
Report
- Report Number
- 3003855635-2009-00009
- Event Type
- Malfunction
- Date Received
- December 4, 2009
- Date of Event
- November 5, 2009
- Report Date
- December 1, 2009
- Manufacturer
- ATLAS SPINE INC.
- Product Code
- HXX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PERFORMED VISUAL EXAM TO THE SCREWDRIVER SLEEVE, AND FOUND THAT THE RETAINING SPRING WAS MISSING. THE DEVICE WORKED FINE DURING PRIOR SURGERY; THE SPRING MAY HAVE FALLEN OUT DURING THE CLEANING/STERILIZATION STAGE PRIOR TO THIS SURGERY.
Description of Event or Problem · 1
THE SLEEVE SLIPPED OFF PUTTING A SCREW ON SCREWDRIVER AND DURING IMPLANT. THE DOCTOR REMOVED THE SLEEVE, AND CONTINUED IMPLANTING THE SCREWS WITHOUT THE SCREWDRIVER SLEEVE. THE SURGERY WAS DELAYED FOR FEW SECONDS WITH NO COMPLICATIONS TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASSEMBLY, SCREWDRIVER SLEEVE, VERTEVIEW | SCREWDRIVER SLEEVE | HXX | ATLAS SPINE INC. | 00444 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |