Brand Name | STABILIZATION SCREW, D=2.4MM, L=22MM, RH |
Type of Device | STABILIZATION SCREW, D=2.4MM, L=22MM, RH |
Manufacturer (Section D) |
I.T.S. GMBH |
autal 28 |
lassnitzh[?]he, styria 8301 |
AU 8301 |
|
MDR Report Key | 9450378 |
MDR Text Key | 206803045 |
Report Number | 3004369035-2019-00161 |
Device Sequence Number | 1 |
Product Code |
HWC
|
UDI-Device Identifier | 09120047294758 |
UDI-Public | 09120047294758 |
Combination Product (y/n) | N |
PMA/PMN Number | K033756 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Type of Report
| Initial,Followup |
Report Date |
12/11/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/11/2019 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 37241-22 |
Device Catalogue Number | 37241-22 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 12/03/2019 |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|