Brand Name | ATTUNE MES SIZING/ROT GDE |
Type of Device | SIZING/MEASURING INSTRUMENTS |
Manufacturer (Section D) |
DEPUY IRELAND - 9616671 |
loughbeg ringaskiddy co. |
cork |
EI |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic dr. |
|
warsaw IN 46582 0988 |
|
Manufacturer Contact |
chad
gibson
|
700 orthopaedic dr. |
in |
warsaw, IN 46582-0988
|
5743725905
|
|
MDR Report Key | 7181665 |
MDR Text Key | 96946017 |
Report Number | 1818910-2018-50864 |
Device Sequence Number | 1 |
Product Code |
HWT
|
UDI-Device Identifier | 10603295434061 |
UDI-Public | 10603295434061 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | NI |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
12/15/2017 |
1 Device 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 | 254400525 |
Device Lot Number | ABF62958 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/24/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/15/2017 |
Initial Date FDA Received | 01/11/2018 |
Supplement Dates Manufacturer Received | 01/24/2018 07/23/2018
|
Supplement Dates FDA Received | 02/02/2018 08/17/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/03/2016 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|