Brand Name | ATTUNE REVISION SLEVE IMPACTR |
Type of Device | IMPACTORS |
Manufacturer (Section D) |
DEPUY IRELAND - 9616671 |
loughbeg ringaskiddy co. |
cork |
EI |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic dr. |
|
warsaw IN 46581 0988 |
|
Manufacturer Contact |
kara
ditty-bovard
|
1210 ward avenue |
west chester, PA 19380
|
6107428552
|
|
MDR Report Key | 8261601 |
MDR Text Key | 133554549 |
Report Number | 1818910-2019-81460 |
Device Sequence Number | 1 |
Product Code |
HWA
|
UDI-Device Identifier | 10603295440222 |
UDI-Public | 10603295440222 |
Combination Product (y/n) | N |
Reporter Country Code | AS |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
12/19/2018 |
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 | 254600424 |
Device Lot Number | AB3912742 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/19/2018 |
Initial Date FDA Received | 01/18/2019 |
Supplement Dates Manufacturer Received | 01/28/2019
|
Supplement Dates FDA Received | 02/04/2019
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/16/2017 |
Is the Device Single Use? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|