Brand Name | NOBELREPLACE CC RP 4.3X8MM |
Type of Device | ENDOSSEOUS DENTAL IMPLANT |
Manufacturer (Section D) |
NOBEL BIOCARE AB |
dimbovägen 2 |
karlskoga 69151 |
SW 69151 |
|
MDR Report Key | 18662072 |
MDR Text Key | 334797514 |
Report Number | 2027971-2024-042112 |
Device Sequence Number | 1 |
Product Code |
DZE
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Dentist
|
Type of Report
| Initial |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/07/2024 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 36704 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/23/2024 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Distributor Facility Aware Date | 01/19/2024 |
Event Location |
Outpatient Treatment Facility
|
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 | 47 YR |
Patient Sex | Male |