Brand Name | NOBELACTIVE INTERNAL RP 4.3X10MM |
Type of Device | ENDOSSEOUS DENTAL IMPLANT |
Manufacturer (Section D) |
NOBEL BIOCARE USA INC |
22725 savi ranch |
yorba linda CA 92887 4609 |
|
Manufacturer (Section G) |
NOBEL BIOCARE USA INC |
22725 savi ranch |
|
yorba linda CA 92887 4609 |
|
Manufacturer Contact |
gayco
meel
|
popeweg 72 |
venlo 5928 -SC
|
NL
5928 SC
|
623202508
|
|
MDR Report Key | 16703279 |
MDR Text Key | 312904436 |
Report Number | 2027971-2023-061883 |
Device Sequence Number | 1 |
Product Code |
DZE
|
UDI-Device Identifier | 07332747160062 |
UDI-Public | (01)07332747160062(10)13140941(17)271020 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K071370 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Dentist
|
Type of Report
| Initial |
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 |
Health Professional
|
Device Model Number | 34131 |
Device Catalogue Number | 34131 |
Device Lot Number | 13140941 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 04/07/2023 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 11/21/2022 |
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) |
Required Intervention;
|
Patient Age | 68 YR |
Patient Sex | Female |