Brand Name | ATTUNE EM TIBIAL DIST UPROD |
Type of Device | ATTUNE INSTRUMENTS : ALIGNMENT DEVICES |
Manufacturer (Section D) |
DEPUY IRELAND 9616671 |
loughbeg, ringaskiddy co. |
cork |
EI |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic drive |
|
warsaw IN 46582 0988 |
|
Manufacturer Contact |
chad
gibson
|
700 orthopaedic drive |
warsaw, IN 46582-0988
|
5743725905
|
|
MDR Report Key | 7722385 |
MDR Text Key | 115107653 |
Report Number | 1818910-2018-65278 |
Device Sequence Number | 1 |
Product Code |
LXH
|
UDI-Device Identifier | 10603295129752 |
UDI-Public | 10603295129752 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup,Followup |
Report Date |
07/02/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 254400003 |
Device Lot Number | PG234330 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/23/2018 |
Initial Date Manufacturer Received |
07/02/2018 |
Initial Date FDA Received | 07/26/2018 |
Supplement Dates Manufacturer Received | 08/09/2018 08/24/2018
|
Supplement Dates FDA Received | 08/10/2018 08/27/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/26/2014 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |