Brand Name | UNKNOWN TOOL |
Type of Device | ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS |
Manufacturer (Section D) |
DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) |
aminogatan 1 |
molndal, S-431 21 |
SW S-431 21 |
|
Manufacturer (Section G) |
DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) |
aminogatan 1 |
|
molndal, S-431 21 |
SW
S-431 21
|
|
Manufacturer Contact |
karl
nittinger
|
221 w. philadelphia st. |
suite 60w |
york, PA 17401
|
7178494424
|
|
MDR Report Key | 8000020 |
MDR Text Key | 124837322 |
Report Number | 9612468-2018-00004 |
Device Sequence Number | 1 |
Product Code |
NDP
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | NA |
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 |
10/24/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/24/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 09/28/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|