Brand Name | CONTACT RC INICELL |
Type of Device | DENTAL IMPLANT |
Manufacturer (Section D) |
THOMMEN MEDICAL AG |
neckarsulmstrasse 28 |
2540 grenchen |
grenchen, switzerland |
SZ |
|
MDR Report Key | 7367188 |
MDR Text Key | 103353728 |
Report Number | 3003708589-2018-00055 |
Device Sequence Number | 1 |
Product Code |
DZE
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Dentist
|
Type of Report
| Initial |
Report Date |
03/22/2018,03/01/2018 |
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 |
Dentist
|
Device Expiration Date | 05/11/2022 |
Device Model Number | 4.23.223 |
Device Catalogue Number | 4.23.223 |
Device Lot Number | 15801 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/19/2018 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 03/22/2018 |
Distributor Facility Aware Date | 03/16/2018 |
Event Location |
Outpatient Treatment Facility
|
Date Report to Manufacturer | 03/19/2018 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 03/23/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 71 YR |
|
|