Brand Name | SPIRAL DRILL, D=2.5MM, L=220MM, AO CONNECTOR |
Type of Device | SPIRAL DRILL, D=2.5MM, L=220MM, AO CONNECTOR |
Manufacturer (Section D) |
I.T.S. GMBH |
autal 28 |
lassnitzh?he, 8301 |
AU 8301 |
|
Manufacturer (Section G) |
I.T.S. GMBH |
autal 28 |
|
lassnitzh?he, 8301 |
AU
8301
|
|
Manufacturer Contact |
florian
grill
|
autal 28 |
lassnitzh?he, 8301
|
AU
8301
|
|
MDR Report Key | 8756577 |
MDR Text Key | 150279020 |
Report Number | 3004369035-2019-00007 |
Device Sequence Number | 1 |
Product Code |
HTW
|
UDI-Device Identifier | 09120047301357 |
UDI-Public | 09120047301357 |
Combination Product (y/n) | N |
Reporter Country Code | CO |
PMA/PMN Number | K051412 |
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 |
06/19/2019 |
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 | 61253-220 |
Device Catalogue Number | 61253-220 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
06/18/2019 |
Initial Date FDA Received | 07/03/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|