Brand Name | CAMLOG PROGRESSIVE LINE IMPLANT |
Type of Device | CAMLOG PROGRESSIVE LINE IMPLANT |
Manufacturer (Section D) |
ALTATEC GMBH |
maybachstr. 5 |
wimsheim, 71299 |
GM 71299 |
|
Manufacturer (Section G) |
ALTATEC GMBH |
maybachstr. 5 |
|
wimsheim, 71299 |
GM
71299
|
|
Manufacturer Contact |
raphael
brausch
|
maybachstr. 5 |
wimsheim, 71299
|
GM
71299
|
|
MDR Report Key | 13392348 |
MDR Text Key | 284684443 |
Report Number | 9613866-2022-65556 |
Device Sequence Number | 1 |
Product Code |
DZE
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Dentist
|
Type of Report
| Initial |
Report Date |
01/31/2022 |
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 Model Number | K1076.3813 |
Device Catalogue Number | K1076.3813 |
Device Lot Number | 0020104280 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/25/2022
|
Initial Date FDA Received | 01/31/2022 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 66 YR |
Patient Sex | Female |
|
|