Brand Name | NOBELACTIVE INTERNAL RP 5.0X10MM |
Type of Device | ENDOSSEOUS DENTAL IMPLANT |
Manufacturer (Section D) |
NOBEL BIOCARE AB |
dimbovägen 2 |
karlskoga 69151 |
SW 69151 |
|
MDR Report Key | 16754332 |
MDR Text Key | 313438653 |
Report Number | 2027971-2023-064554 |
Device Sequence Number | 1 |
Product Code |
DZE
|
UDI-Device Identifier | 07332747160109 |
UDI-Public | (01)07332747160109(10)12212893(17)271107 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Dentist
|
Type of Report
| Initial |
Report Date |
04/17/2023 |
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 | 34137 |
Device Catalogue Number | 34137 |
Device Lot Number | 12212893 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/17/2023 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Report Sent to FDA | 04/17/2023 |
Distributor Facility Aware Date | 03/31/2023 |
Event Location |
Outpatient Treatment Facility
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 04/17/2023 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
A
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 50 YR |
Patient Sex | Prefer Not To Disclose |