FDA Adverse Event
Other
Summary report: N
CDO SYSTEM
MDR report key: 321963
·
Received March 19, 2001
Report
- Report Number
- 1125620-2001-00001
- Event Type
- Other
- Date Received
- March 19, 2001
- Manufacturer
- AMERICAN OSTEOMEDIX
- Product Code
- LXH
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INCIDENT: WHILE ATTEMPTING TO PERFORM A PERCUTANEOUS DELIVERY TO A FRACTURED L4 VERTEBRA ON AN ACCIDENT VICTIM, THE OUTER CANNULAE (100.103) BECAME WEDGED INTO DENSE, HARD BONE AND COULD NOT BE EXTRACTED. THE GUIDEWIRE AND ALIGNING CANNULA WERE REMOVED WITH DIFFICULTY, BUT THE OUTER CANNULAE FRACTURED OFF DURING EXTRACTION, LEAVING THE DISTAL END IMPLANTED IN THE VERTEBRAL BODY. THE CASE WAS ABORTED AND THE FRAGMENT LEFT IMPLANTED. PARTS DISPOSITION: THE HOSPITAL RETURNED 2 OUTER CANNULAE, ONE ALIGNING CANNULA AND 1 GUIDEWIRE FOR INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 12237 | CDO SYSTEM | TAMP & CANNULAE SYSTEM | LXH | AMERICAN OSTEOMEDIX | NA | 0091 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |