Brand Name | ASTRATECH IMPL EV 4.2S 9MM OS |
Type of Device | ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS |
Manufacturer (Section D) |
DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) |
aminogatan 1 |
molndal vastra gotalands lan [ S-431 21 |
SW S-431 21 |
|
Manufacturer (Section G) |
DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) |
aminogatan 1 |
|
molndal vastra gotalands lan [ S-431 21 |
SW
S-431 21
|
|
Manufacturer Contact |
hannah
seevaratnam
|
221 west philadelphia st. |
york, PA 17401
|
7178457511
|
|
MDR Report Key | 16050422 |
MDR Text Key | 306157008 |
Report Number | 9612468-2022-07388 |
Device Sequence Number | 1 |
Product Code |
NHA
|
Combination Product (y/n) | N |
Reporter Country Code | PL |
PMA/PMN Number | MULTIPLE |
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,Followup |
Report Date |
01/26/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/27/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Catalogue Number | 26322 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Distributor Facility Aware Date | 12/16/2022 |
Date Manufacturer Received | 12/16/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Type of Device Usage |
A
|
Patient Sequence Number | 1 |
Treatment | REF: (B)(4)LOT, 495361NAME: ASTRA TECH IMPLANT |
Patient Outcome(s) |
Required Intervention;
|