Brand Name | 12.6CM TAPERED ATTACH, BM |
Type of Device | BUR, SURGICAL, GENERAL & PLASTIC SURGERY - ATTACHMENT |
Manufacturer (Section D) |
DEPUY SYNTHES POWER TOOLS |
4500 riverside drive |
palm beach gardens FL 33410 |
|
Manufacturer (Section G) |
DEPUY SYNTHES POWER TOOLS |
4500 riverside drive |
|
palm beach gardens FL 33410 |
|
Manufacturer Contact |
rodney
crain
|
4500 riverside drive |
palm beach gardens, FL 33410
|
5616271080
|
|
MDR Report Key | 3690316 |
MDR Text Key | 4243192 |
Report Number | 1045834-2014-11687 |
Device Sequence Number | 1 |
Product Code |
GFF
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | PK974025 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Service and Testing Personnel
|
Type of Report
| Initial |
Report Date |
03/05/2014 |
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 | B-TURQ-L |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/25/2014 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/05/2014
|
Initial Date FDA Received | 03/20/2014 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/02/2011 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |