FDA Adverse Event
Injury
Summary report: N
CSS CANNULATED SCREW SYSTEM
MDR report key: 1964048
·
Received January 11, 2011
Report
- Report Number
- 3005039508-2010-00027
- Event Type
- Injury
- Date Received
- January 11, 2011
- Date of Event
- December 13, 2010
- Report Date
- December 13, 2010
- Manufacturer
- ORTHOHELIX SURGICAL DESIGN
- Product Code
- HWC
- PMA / PMN Number
- K060428
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE SURGEON WAS CONTACTED 4 TIMES AND THE SALES REP CONTACTED 3 TIMES WITHOUT OBTAINING ANY FURTHER INFORMATION REGARDING THIS CASE.
Description of Event or Problem · 1
PER THE SALES REP, THE SURGEON REPORTED A BROKEN 5.5 SCREW POST-OP AFTER HAVING DONE A TN CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CSS CANNULATED SCREW SYSTEM | BONE FIXATION SCREWS | HWC | ORTHOHELIX SURGICAL DESIGN | MSD-010-55-XXX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |