Brand Name | CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) |
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 |
carlos
gordian-arroyo
|
4555 riverside drive |
palm beach gardens, FL 33410
|
5619713230
|
|
MDR Report Key | 18999715 |
MDR Text Key | 338913295 |
Report Number | 0001038806-2024-00609 |
Device Sequence Number | 1 |
Product Code |
NHA
|
UDI-Device Identifier | 00844868021063 |
UDI-Public | (01)00844868021063(17)280113(10)2022120370 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K092341 |
Exemption Number | 5645646 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/27/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/28/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Catalogue Number | ILPC442U |
Device Lot Number | 2022120370 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/11/2024 |
Is the Reporter a Health Professional? |
Yes
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/12/2023 |
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 Sex | Prefer Not To Disclose |
Patient Ethnicity | Non Hispanic |