Brand Name | PEDIATRIC CRANIOTOME |
Type of Device | MOTOR, DRILL, ELECTRIC ¿ CRANIOTOME |
Manufacturer (Section D) |
DEPUY SYNTHES POWER TOOLS |
4500 riverside dr. |
palm beach gardens FL 33410 |
|
Manufacturer (Section G) |
DEPUY SYNTHES POWER TOOLS |
4500 riverside dr. |
|
palm beach gardens FL 33410 |
|
Manufacturer Contact |
rodney
crain
|
4500 riverside dr. |
palm beach gardens, FL 33410
|
5614943766
|
|
MDR Report Key | 3593396 |
MDR Text Key | 4139224 |
Report Number | 1045834-2013-12427 |
Device Sequence Number | 1 |
Product Code |
HBC
|
Combination Product (Y/N) | N |
Reporter Country Code | IT |
PMA/PMN Number | K011444 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Distributor |
Reporter Occupation |
|
Type of Report
| Initial |
Report Date |
01/13/2011 |
1 Device Was Involved in the Event |
|
0 PatientS WERE Involved in the Event: | |
Date FDA Received | 09/10/2013 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
HEALTH PROFESSIONAL
|
Device Catalogue Number | CRANI-P |
Was Device Available For Evaluation? |
Yes
|
Date Returned to Manufacturer | 01/18/2011 |
Date Manufacturer Received | 01/13/2011 |
Was Device Evaluated By Manufacturer? |
No
|
Date Device Manufactured | 03/24/2006 |
Is The Device Single Use? |
No
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Invalid Data
|
|
|