Brand Name | SMARTSET GMV 40G US EO |
Type of Device | BONE CEMENT : BONE CEMENT |
Manufacturer (Section D) |
DEPUY ORTHOPAEDIC INC, 1818910 |
700 orthopaedic drive |
blackpool |
warsaw 46582 |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDIC INC, 1818910 |
700 orthopaedic drive |
|
warsaw 46582 |
|
Manufacturer Contact |
kara
ditty-bovard
|
700 orthopaedic drive |
warsaw, PA 46582-XXXX
|
6103142063
|
|
MDR Report Key | 8069993 |
MDR Text Key | 127116523 |
Report Number | 1818910-2018-75439 |
Device Sequence Number | 1 |
Product Code |
LOD
|
Combination Product (y/n) | N |
PMA/PMN Number | K081163 |
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,Followup |
Report Date |
10/24/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 545050501 |
Device Lot Number | 8428658 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/24/2018
|
Initial Date FDA Received | 11/14/2018 |
Supplement Dates Manufacturer Received | 11/15/2018 11/27/2018
|
Supplement Dates FDA Received | 11/16/2018 11/28/2018
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/15/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|