Brand Name | VECTORTAS MINI-SCREW |
Type of Device | ACCESSORIES, IMPLANT, DENTAL ENDOSSEOUS, PRODUCT CODE |
Manufacturer (Section D) |
ORMCO CORPORATION |
1332 south lone hill ave. |
glendora CA 91740 |
|
Manufacturer (Section G) |
ORMCO CORPORATION |
1332 south lone hill ave. |
|
glendora CA 91740 |
|
Manufacturer Contact |
suzette
rampair-johnson
|
1332 south lone hill ave. |
glendora, CA 91740
|
9099625730
|
|
MDR Report Key | 7670794 |
MDR Text Key | 113748204 |
Report Number | 2016150-2018-00047 |
Device Sequence Number | 1 |
Product Code |
NDP
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup |
Report Date |
04/30/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/09/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Other
|
Device Catalogue Number | 601-0022 |
Device Lot Number | 6062034 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 06/27/2018 |
Was Device Evaluated by Manufacturer? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|