Brand Name | SELF-DRILLING ANCHORAGE IMPL MB TI1.6X11 |
Type of Device | ENDOSSEOUS DENTAL IMPLANT |
Manufacturer (Section D) |
JJGC S.A. |
av. juscelino kubitschek de |
oliveira, 3291 cic |
curitiba PR 81270 -200 |
BR 81270-200 |
|
Manufacturer (Section G) |
JJGC S.A. |
av. juscelino kubitschek de |
oliveira, 3291 cic |
curitiba PR 81270 -200 |
BR
81270-200
|
|
Manufacturer Contact |
jennifer
jackson
|
60 minuteman road |
andover, MA 01810
|
9787472509
|
|
MDR Report Key | 17725118 |
MDR Text Key | 323151429 |
Report Number | 3008261720-2023-019133 |
Device Sequence Number | 1 |
Product Code |
OAT
|
UDI-Device Identifier | 07898237567624 |
UDI-Public | 07898237567624 |
Combination Product (y/n) | N |
Reporter Country Code | PO |
PMA/PMN Number | K102769 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional |
Reporter Occupation |
Dentist
|
Type of Report
| Initial |
Report Date |
09/11/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 109.498 |
Device Lot Number | FFF61 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/17/2023 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 09/11/2023 |
Event Location |
Other
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 09/11/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/22/2021 |
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 | 33 YR |
Patient Sex | Female |