Brand Name | OSSEOSPEED TX 5.0S - 9 MM |
Type of Device | IMPLANT, ENDOSSEOUS, ROOT-FORM |
Manufacturer (Section D) |
DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) |
aminogatan 1 |
molndal, vastra gotalands lan [se-14] S-431 21 |
SW S-431 21 |
|
Manufacturer (Section G) |
DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) |
aminogatan 1 |
|
molndal, vastra gotalands lan [se-14] S-431 21 |
SW
S-431 21
|
|
Manufacturer Contact |
joleta
ness
|
221 w. philadelphia st. |
suite 60w |
york, PA 17401
|
7178494593
|
|
MDR Report Key | 12340453 |
MDR Text Key | 267209019 |
Report Number | 9612468-2021-57998 |
Device Sequence Number | 1 |
Product Code |
DZE
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K053384 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Dentist
|
Type of Report
| Initial,Followup |
Report Date |
01/20/2022 |
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 | 24971 |
Device Lot Number | 464736 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/19/2021 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 08/18/2021 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 01/20/2022
|
Was Device Evaluated by Manufacturer? |
No
|
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;
|
|
|