Brand Name | BRANEMARK SYSTEM MK III TIU RP 3.75X13MM |
Type of Device | ENDOSSEOUS DENTAL IMPLANT |
Manufacturer (Section D) |
NOBEL BIOCARE AB |
dimbovgen 2 |
karlskoga, SE-69 151 |
SW SE-69151 |
|
MDR Report Key | 9066475 |
MDR Text Key | 160332052 |
Report Number | 2027971-2019-21808 |
Device Sequence Number | 1 |
Product Code |
DZE
|
UDI-Device Identifier | 7332747001198 |
UDI-Public | (01)7332747001198(10)653701(17)100129 |
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 |
09/15/2019,06/25/2019 |
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 Expiration Date | 01/29/2010 |
Device Catalogue Number | 28915 |
Device Lot Number | 653701 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/25/2019 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 09/15/2019 |
Distributor Facility Aware Date | 06/25/2019 |
Event Location |
Outpatient Treatment Facility
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 09/15/2019 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 69 YR |