FDA Adverse Event
Injury
Summary report: N
CASPAR DISTR PIN 14 MMSTER
MDR report key: 840946
·
Received April 14, 2007
Report
- Report Number
- 3005673311-2007-00019
- Event Type
- Injury
- Date Received
- April 14, 2007
- Date of Event
- February 2, 2007
- Report Date
- April 13, 2007
- Manufacturer
- AESCULAP IMPLANT SYSTEMS, INC.
- Product Code
- LXH
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLES WERE DISCARDED. ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO OUR MFR IN ANOTHER COUNTRY, FOR FURTHER ANALYSIS.
Description of Event or Problem · 1
DURING A THREE LEVEL, ANTERIOR CERVICAL DISKECTOMY AND FUSION, TWO DISTRACTION PINS BROKE OFF INSIDE THE VERTEBRAL BODY UPON REMOVAL AT C3 AND C4. LEFT DISTAL PORTION INSIDE VERTEBRAL BODY C3-4 DUE TO ANY ATTEMPT OF REMOVAL REMAINING PINS WOULD PREVENT THE ABILITY TO FUSE THE VERTEBRAE. SURGERY WAS PROLONGED LESS THAN FIVE MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CASPAR DISTR PIN 14 MMSTER | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | AESCULAP IMPLANT SYSTEMS, INC. | NA | 51340566 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |