Brand Name | LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI) |
Type of Device | ENDOSSEOUS DENTAL IMPLANT |
Manufacturer (Section D) |
ZEST ANCHORS, LLC |
2875 loker avenue east |
carlsbad CA 92010 |
|
Manufacturer Contact |
david
lin
|
2875 loker avenue east |
carlsbad, CA 92010
|
7607437744
|
|
MDR Report Key | 7745331 |
MDR Text Key | 115892550 |
Report Number | 2023950-2018-00319 |
Device Sequence Number | 1 |
Product Code |
DZE
|
Combination Product (y/n) | N |
PMA/PMN Number | K120198 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Type of Report
| Initial,Followup |
Report Date |
09/19/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/02/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
No Information
|
Device Model Number | 07461 |
Device Catalogue Number | 07461 |
Device Lot Number | I202A |
Was Device Available for Evaluation? |
Yes
|
Date Manufacturer Received | 07/12/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
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;
|
|
|