Brand Name | VULCAN CUSTOM DENTAL SURGICAL GUIDE |
Type of Device | DENTAL IMPLANT SURGICAL GUIDE |
Manufacturer (Section D) |
VULCAN CUSTOM DENTAL |
2300 riverchase center |
suite 825 |
birmingham AL 35244 |
|
Manufacturer (Section G) |
VULCAN CUSTOM DENTAL |
2300 riverchase center |
suite 825 |
birmingham AL 35244 |
|
Manufacturer Contact |
brett
muetzel
|
2300 riverchase center |
suite 825 |
birmingham, AL 35244
|
8444842301
|
|
MDR Report Key | 11655823 |
MDR Text Key | 247578174 |
Report Number | 3012481042-2021-00008 |
Device Sequence Number | 1 |
Product Code |
NDP
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Dentist
|
Type of Report
| Initial |
Report Date |
02/26/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/13/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | PRINT003 |
Device Catalogue Number | PRINT003 |
Device Lot Number | CN090280 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/19/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 | 30 YR |