Brand Name | IMPLANT REMOVAL TOOL |
Type of Device | DENTAL IMPLANT |
Manufacturer (Section D) |
IMPLANT DIRECT SYBRON MANUFACTURING LLC |
3050 east hillcrest drive |
thousand oaks CA 91362 |
|
Manufacturer Contact |
karen
manalili
|
3050 east hillcrest drive |
thousand oaks, CA 91362
|
8057785914
|
|
MDR Report Key | 12567441 |
MDR Text Key | 274428056 |
Report Number | 3001617766-2021-05818 |
Device Sequence Number | 1 |
Product Code |
NDP
|
UDI-Device Identifier | 10841307119418 |
UDI-Public | 10841307119418 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Dentist
|
Remedial Action |
Inspection |
Type of Report
| Initial,Followup,Followup |
Report Date |
12/03/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/04/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | IXT |
Device Lot Number | 183394 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/01/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/06/2021 |
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;
|
Patient Age | 58 YR |
Patient Sex | Female |
Patient Weight | 79 KG |
|
|