Type of Device | BONE GRAFTING MATERIAL, ANIMAL SOURCE |
Manufacturer (Section D) |
DATUM DENTAL LTD. |
1, bat sheva st. |
lod hamerkaz 71201 01 |
IS 7120101 |
|
MDR Report Key | 14844732 |
MDR Text Key | 294882590 |
Report Number | 1222802-2022-00004 |
Device Sequence Number | 1 |
Product Code |
NPM
|
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 |
06/28/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/28/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Catalogue Number | OXB0250 |
Device Lot Number | OB25000231 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Distributor Facility Aware Date | 06/21/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Type of Device Usage |
A
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|