Brand Name | MBT REV TIB TRAY SIZE 2 15MM |
Type of Device | MBT TIBIAL TRAY : KNEE TIBIAL TRAY |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic drive |
warsaw IN 46581 0988 |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic drive |
|
warsaw IN 46581 |
|
Manufacturer Contact |
chad
gibson
|
700 orthopaedic drive |
warsaw, IN 46581-0988
|
5743725905
|
|
MDR Report Key | 7147572 |
MDR Text Key | 95811232 |
Report Number | 1818910-2017-52529 |
Device Sequence Number | 1 |
Product Code |
MRA
|
UDI-Device Identifier | 10603295026006 |
UDI-Public | 10603295026006 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P070026 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup |
Report Date |
11/29/2017 |
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 | 129435215 |
Device Lot Number | FC9GJ1 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/29/2017
|
Initial Date FDA Received | 12/27/2017 |
Supplement Dates Manufacturer Received | 05/03/2018
|
Supplement Dates FDA Received | 05/09/2018
|
Date Device Manufactured | 01/27/2011 |
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;
|
Patient Age | 64 YR |
|
|