Brand Name | CORTICAL STABILIZATION SCREW, D=3.0MM, L=12MM, RH |
Type of Device | CORTICAL STABILIZATION SCREW, D=3.0MM, L=12MM, RH |
Manufacturer (Section D) |
I.T.S. GMBH |
autal 28 |
lassnitzh[?]he, styria 8301 |
AU 8301 |
|
Manufacturer (Section G) |
I.T.S. GMBH |
autal 28 |
|
lassnitzh[?]he, styria 8301 |
AU
8301
|
|
Manufacturer Contact |
florian
grill
|
autal 28 |
lassnitzh[?]he, styria 8301
|
AU
8301
|
|
MDR Report Key | 15915714 |
MDR Text Key | 307582441 |
Report Number | 3004369035-2022-00167 |
Device Sequence Number | 1 |
Product Code |
HWC
|
UDI-Device Identifier | 09120047293829 |
UDI-Public | 09120047293829 |
Combination Product (y/n) | Y |
Reporter Country Code | US |
PMA/PMN Number | K033756 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
12/05/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/05/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 37304-12 |
Device Catalogue Number | 37304-12 |
Device Lot Number | 86/341245 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/02/2022 |
Date Manufacturer Received | 11/01/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|