Brand Name | CERTAIN TITANIUM HEXED SCREW |
Type of Device | DENTAL SCREW |
Manufacturer (Section D) |
BIOMET 3I |
4555 riverside drive |
palm beach gardens FL 33410 |
|
Manufacturer (Section G) |
BIOMET 3I |
4555 riverside drive |
|
palm beach gardens FL 33410 |
|
Manufacturer Contact |
susanne
taylor
|
4555 riverside drive |
palm beach gardens, FL 33410
|
5617766700
|
|
MDR Report Key | 16051353 |
MDR Text Key | 308539524 |
Report Number | 0001038806-2022-01976 |
Device Sequence Number | 1 |
Product Code |
NHA
|
Combination Product (y/n) | N |
Reporter Country Code | SP |
PMA/PMN Number | K072642 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility |
Reporter Occupation |
Dentist
|
Type of Report
| Initial,Followup |
Report Date |
04/18/2023 |
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 Model Number | IUNIHT |
Device Catalogue Number | IUNIHT |
Device Lot Number | 1248839 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/09/2022 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
12/09/2022 |
Initial Date FDA Received | 12/27/2022 |
Supplement Dates Manufacturer Received | 04/05/2023
|
Supplement Dates FDA Received | 04/18/2023
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/17/2021 |
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 | 69 YR |
Patient Sex | Female |
|
|