Brand Name | FIXTURE REMOVER SCREW M 1.6 |
Type of Device | IMPLANT REMOVER SCREW |
Manufacturer (Section D) |
NEOBIOTECH |
e-space #1010, guro-dong |
guro-gu |
seoul, korea 152-7 89 |
KS 152-789 |
|
MDR Report Key | 8629416 |
MDR Text Key | 145689150 |
Report Number | 0001038806-2019-00436 |
Device Sequence Number | 1 |
Product Code |
NDP
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Type of Report
| Initial,Followup |
Report Date |
05/21/2019,08/22/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/21/2019 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | FRS16 |
Device Lot Number | TT030217110128 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Date Report Sent to FDA | 05/21/2019 |
Distributor Facility Aware Date | 04/25/2019 |
Event Location |
Other
|
Date Report to Manufacturer | 05/21/2019 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|