Brand Name | MOR |
Type of Device | IMPLANT |
Manufacturer (Section D) |
STERNGOLD DENTAL LLC |
23 frank mossberg drive |
attleboro MA 02703 |
|
MDR Report Key | 9292559 |
MDR Text Key | 191833766 |
Report Number | 2921595-2019-00020 |
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 |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Dentist
|
Type of Report
| Initial |
Report Date |
11/07/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 03/01/2024 |
Device Model Number | 901483 |
Device Lot Number | Y326519 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/08/2019 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/26/2019
|
Initial Date FDA Received | 11/07/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/18/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 63 YR |
|
|