Brand Name | ATTUNE A-P CHAMFER BLOCK SZ 3 |
Type of Device | ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES |
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
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
6107428552
|
|
MDR Report Key | 12549994 |
MDR Text Key | 273890782 |
Report Number | 1818910-2021-21500 |
Device Sequence Number | 1 |
Product Code |
HTZ
|
UDI-Device Identifier | 10603295395348 |
UDI-Public | 10603295395348 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
09/21/2021 |
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 Model Number | 2545-00-153 |
Device Catalogue Number | 254500153 |
Device Lot Number | PG228358 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/21/2021 |
Initial Date FDA Received | 09/29/2021 |
Supplement Dates Manufacturer Received | 11/10/2021
|
Supplement Dates FDA Received | 11/11/2021
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/01/2013 |
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 |
Patient Age | 62 YR |
Patient Sex | Male |