Brand Name | SURGIGUIDE GUIDE |
Type of Device | VARIOUS, EBG, LLZ, DZE |
Manufacturer (Section D) |
DENTSPLY IMPLANTS N.V. |
hasselt limburg |
BE |
|
Manufacturer Contact |
helen
lewis
|
221 w. philadelphia st., ste 60 |
susquehanna commerce center w |
york, PA 17401
|
7178457511
|
|
MDR Report Key | 4990628 |
MDR Text Key | 22640731 |
Report Number | 3007362683-2015-00015 |
Device Sequence Number | 1 |
Product Code |
EBG
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K113739 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Dentist
|
Report Date |
03/30/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/06/2015 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 37502 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 03/27/2015 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/30/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/20/2015 |
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;
|
|
|