Brand Name | PALATAL IMPLANT 4.1, L 4.2MM |
Type of Device | ENDOSSEOUS DENTAL IMPLANT |
Manufacturer (Section D) |
INSTITUT STRAUMANN AG |
peter merian-weg 12 |
basel 04002 |
CH 04002 |
|
Manufacturer (Section G) |
INSTITUT STRAUMANN AG |
peter merian-weg 12 |
|
basel 04002 |
CH
04002
|
|
Manufacturer Contact |
jennifer
jackson
|
60 minuteman road |
andover, MA 01810
|
9787472509
|
|
MDR Report Key | 10259054 |
MDR Text Key | 198589248 |
Report Number | 0009613348-2020-37616 |
Device Sequence Number | 1 |
Product Code |
OAT
|
UDI-Device Identifier | 07630031718167 |
UDI-Public | 07630031718167 |
Combination Product (y/n) | N |
Reporter Country Code | DE |
PMA/PMN Number | K060062 |
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 |
07/10/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/10/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | Palatal-System |
Device Catalogue Number | 042.335S |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/16/2020 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 07/10/2020 |
Event Location |
Other
|
Was Device Evaluated by Manufacturer? |
Yes
|
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 | 14 YR |