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 |
|
Manufacturer (Section G) |
NOBEL BIOCARE AB |
dimbovgen 2 |
|
karlskoga, SE-69 151 |
SW
SE-69151
|
|
Manufacturer Contact |
pramod
gouda
|
kozakkenberg 4 |
5951 dl belfeld,
|
NL
|
|
MDR Report Key | 9063153 |
MDR Text Key | 158951332 |
Report Number | 9611993-2019-15110 |
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 |
PMA/PMN Number | K022562 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Dentist
|
Type of Report
| Initial |
Report Date |
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
|
Initial Date Manufacturer Received |
06/25/2019
|
Initial Date FDA Received | 09/15/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/02/2005 |
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 | 69 YR |