Brand Name | SIMPLANT GUIDE |
Type of Device | ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS |
Manufacturer (Section D) |
DENTSPLY IMPLANTS N.V. |
research campus 10 |
hasselt limburg, B-350 0 |
BE B-3500 |
|
MDR Report Key | 11031590 |
MDR Text Key | 222267110 |
Report Number | 3007362683-2020-00003 |
Device Sequence Number | 1 |
Product Code |
NDP
|
Combination Product (y/n) | N |
PMA/PMN Number | NA#S-P#NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Type of Report
| Initial,Followup |
Report Date |
03/31/2021 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 37502 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
11/17/2020 |
Initial Date FDA Received | 12/17/2020 |
Supplement Dates Manufacturer Received | 11/17/2020
|
Supplement Dates FDA Received | 03/31/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|