FDA Adverse Event
Malfunction
Summary report: N
CORAIL AMT NECK SEG 125D KLA
MDR report key: 8190106
·
Received December 21, 2018
Report
- Report Number
- 1818910-2018-79015
- Event Type
- Malfunction
- Date Received
- December 21, 2018
- Date of Event
- January 23, 2018
- Report Date
- November 29, 2018
- Manufacturer
- DEPUY FRANCE SAS - 3003895575
- Product Code
- LXH
- UDI-DI
- 10603295325154
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT IS JUSTIFIED, EXAMINATION OF THE PHOTOS CONFIRMED THE FAILURE MODE NO FURTHER ACTIONS IDENTIFIED. THE COMPLAINT SHALL BE CLOSED WITH A JUSTIFIED CONCLUSION; ENTERED INTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. POST MARKET SURVEILLANCE IS PER SEP 419. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem · 1
BLOOD AND DEBRI GETS CAUGHT BEHIND NECK TRIAL O RINGS. NO DELAY TO PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1030699 | CORAIL AMT NECK SEG 125D KLA | HIP INSTRUMENTS : FEMORAL TRIALS | LXH | DEPUY FRANCE SAS - 3003895575 | 10603295325154 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |