Brand Name | ATTUNE CONV SHIM SZ3 18MM |
Type of Device | ATTUNE INSTRUMENTS : TIBIAL TRIALS |
Manufacturer (Section D) |
DEPUY IRELAND - 9616671 |
loughbeg ringaskiddy co. |
cork |
EI |
|
Manufacturer (Section G) |
DEPUY IRELAND - 9616671 |
loughbeg ringaskiddy co. |
|
cork |
EI
|
|
Manufacturer Contact |
kara
ditty-bovard
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
6103142063
|
|
MDR Report Key | 8273909 |
MDR Text Key | 133970414 |
Report Number | 1818910-2019-82126 |
Device Sequence Number | 1 |
Product Code |
HWT
|
UDI-Device Identifier | 10603295134978 |
UDI-Public | 10603295134978 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
01/07/2019 |
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 | 254500920 |
Device Lot Number | BFA0RF7 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/07/2019 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/07/2019 |
Initial Date FDA Received | 01/24/2019 |
Supplement Dates Manufacturer Received | 01/07/2019
|
Supplement Dates FDA Received | 01/24/2019
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/27/2014 |
Is the Device Single Use? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |