Brand Name | CORAIL AMT NECK SEG 135D SHORT |
Type of Device | HIP INSTRUMENTS : FEMORAL TRIALS |
Manufacturer (Section D) |
DEPUY FRANCE SAS - 3003895575 |
7 allee irene joliot-curie |
b.p. 256 |
saint priest cedex 69801 |
FR 69801 |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic dr. |
|
warsaw IN 46582 0988 |
|
Manufacturer Contact |
chad
gibson
|
700 orthopaedic dr. |
warsaw, IN 46582-0988
|
5743725905
|
|
MDR Report Key | 7872917 |
MDR Text Key | 120248538 |
Report Number | 1818910-2018-69310 |
Device Sequence Number | 1 |
Product Code |
LZO
|
UDI-Device Identifier | 10603295325185 |
UDI-Public | 10603295325185 |
Combination Product (y/n) | N |
Reporter Country Code | EI |
PMA/PMN Number | K142004 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,other,user facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
08/20/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | L94007 |
Device Lot Number | SO2023042 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/11/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/20/2018
|
Initial Date FDA Received | 09/13/2018 |
Supplement Dates Manufacturer Received | 10/30/2018
|
Supplement Dates FDA Received | 10/31/2018
|
Date Device Manufactured | 06/02/2016 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |