Brand Name | RADIAL IMPLANT, SMALL, RIGHT |
Type of Device | UNI2 TOTAL WRIST IMPLANT SYSTEM |
Manufacturer (Section D) |
INTEGRA LIFESCIENCES CORPORATION OH/USA |
4900 charlemar drive |
4900 charlemar drive |
cincinnati OH 45227 |
|
Manufacturer (Section G) |
INTEGRA LIFESCIENCES CORPORATION OH/USA |
4900 charlemar drive |
|
cincinnati OH 45227 |
|
Manufacturer Contact |
maria
leonard
|
311 enterprise drive |
plainsboro, NJ 08536
|
6099362393
|
|
MDR Report Key | 5378379 |
MDR Text Key | 36349269 |
Report Number | 3004608878-2016-00020 |
Device Sequence Number | 1 |
Product Code |
JWJ
|
Combination Product (y/n) | N |
PMA/PMN Number | K030037 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
10/21/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/19/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 263200RT |
Device Lot Number | 087628 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/21/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/25/2010 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |