Brand Name | ATTUNE SHIM SZ5 5MM |
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, munster |
EI
|
|
Manufacturer Contact |
kara
ditty-bovard
|
1210 ward avenue |
west chester, PA 19380
|
6107428552
|
|
MDR Report Key | 8432241 |
MDR Text Key | 139194333 |
Report Number | 1818910-2019-87739 |
Device Sequence Number | 1 |
Product Code |
HWT
|
UDI-Device Identifier | 10603295133438 |
UDI-Public | 10603295133438 |
Combination Product (y/n) | N |
Reporter Country Code | NO |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
02/26/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/19/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 254500651 |
Device Lot Number | MVMCYJ970 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 04/18/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/31/2016 |
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 |