Brand Name | MOR |
Type of Device | IMPLANT |
Manufacturer (Section D) |
STERNGOLD DENTAL LLC |
23 frank mossberg drive |
attleboro MA 02703 |
|
Manufacturer Contact |
diane
tiernan
|
23 frank mossberg drive |
attleboro, MA 02703
|
5082265660
|
|
MDR Report Key | 9075371 |
MDR Text Key | 191831086 |
Report Number | 2921595-2019-00002 |
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 |
09/12/2019 |
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? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/15/2021 |
Device Model Number | 901484 |
Device Lot Number | X636716 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/22/2019 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/09/2019
|
Initial Date FDA Received | 09/17/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/27/2016 |
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 | 75 YR |
|
|