Brand Name | TWM |
Type of Device | TORQUE WRENCH |
Manufacturer (Section D) |
IMPLANT DIRECT SYBRON MANUFACTURING LLC |
3050 east hillcrest drive |
thousand oaks, ca |
|
Manufacturer Contact |
adrienne
stott
|
3050 east hillcrest drive |
thousand oaks, ca
|
4443300357
|
|
MDR Report Key | 9742519 |
MDR Text Key | 180519356 |
Report Number | 3001617766-2020-00582 |
Device Sequence Number | 1 |
Product Code |
NDP
|
UDI-Device Identifier | 10841307119265 |
UDI-Public | 10841307119265 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Dentist
|
Remedial Action |
Inspection |
Type of Report
| Initial |
Report Date |
02/21/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | TWM |
Device Catalogue Number | TWM |
Device Lot Number | 143685 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/30/2020 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/23/2020
|
Initial Date FDA Received | 02/21/2020 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 06/10/2019 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|