Brand Name | NOBELPARALLEL CC RP 4.3X13MM |
Type of Device | ENDOSSEOUS DENTAL IMPLANT |
Manufacturer (Section D) |
NOBEL BIOCARE AB |
dimbovägen 2 |
karlskoga 69151 |
SW 69151 |
|
MDR Report Key | 18232269 |
MDR Text Key | 329290006 |
Report Number | 2027971-2023-148192 |
Device Sequence Number | 1 |
Product Code |
DZE
|
UDI-Device Identifier | 07332747161298 |
UDI-Public | (01)07332747161298(10)12220302(17)280318 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Dentist
|
Type of Report
| Initial |
Report Date |
11/29/2023 |
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 Catalogue Number | 37974 |
Device Lot Number | 12220302 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/23/2023 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Report Sent to FDA | 11/29/2023 |
Distributor Facility Aware Date | 11/07/2023 |
Event Location |
Outpatient Treatment Facility
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 11/29/2023 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
A
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|