Brand Name | Z5 |
Type of Device | ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS |
Manufacturer (Section D) |
Z-SYSTEMS AG |
werkhofstrasse 5 |
oensingen, solothurn 4702 |
SZ 4702 |
|
Manufacturer (Section G) |
Z-SYSTEMS AG |
werkhofstrasse 5 |
|
oensingen, solothurn 4702 |
SZ
4702
|
|
Manufacturer Contact |
rubino
di girolamo
|
werkhofstrasse 5 |
oensingen, solothurn 4702
|
SZ
4702
|
|
MDR Report Key | 7880483 |
MDR Text Key | 120392978 |
Report Number | 3006948427-2018-01942 |
Device Sequence Number | 1 |
Product Code |
NHA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K132881 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Dentist
|
Remedial Action |
Replace |
Type of Report
| Initial |
Report Date |
07/24/2018,08/24/2018 |
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 |
No Information
|
Device Model Number | Z5C-A00S |
Device Catalogue Number | Z5C-A00S |
Device Lot Number | 938529 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/24/2018 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 07/24/2018 |
Device Age | 1 YR |
Event Location |
Ambulatory Surgical Facility
|
Date Report to Manufacturer | 07/24/2018 |
Initial Date Manufacturer Received |
07/24/2018 |
Initial Date FDA Received | 09/17/2018 |
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) |
Other;
|
Patient Age | 32 YR |
|
|