FDA Adverse Event
Malfunction
Summary report: N
CORAIL AMT NECK SEG 125D KLA
MDR report key: 7944632
·
Received October 8, 2018
Report
- Report Number
- 1818910-2018-71682
- Event Type
- Malfunction
- Date Received
- October 8, 2018
- Date of Event
- September 20, 2018
- Report Date
- September 20, 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
(B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Additional Manufacturer Narrative · 1
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE DEVICE WAS REVIEWED AND CONFIRMED THERE WAS NO PROBLEM IDENTIFIED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. 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
CORAIL NECK SEGMENTS NOT SITTING ON BRANCHES PROPERLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 782729 | CORAIL AMT NECK SEG 125D KLA | HIP INSTRUMENTS : FEMORAL TRIALS | LXH | DEPUY FRANCE SAS - 3003895575 | UNKNOWN | 10603295325154 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |