Brand Name | SOLIDITY |
Type of Device | CENTER PIECE, TURQUOISE 13MM, HEIGHT 19-27.5MM |
Manufacturer (Section D) |
ULRICH MEDICAL USA |
18221 edison ave. |
chesterfield MO 63005 |
|
Manufacturer (Section G) |
ULRICH GMBH & CO. KG |
buchbrunnenweg 12 |
na |
ulm, 89081 |
GM
89081
|
|
Manufacturer Contact |
louis
milos
|
18221 edison ave. |
chesterfield, MO 63005
|
6365190268
|
|
MDR Report Key | 9526656 |
MDR Text Key | 198551447 |
Report Number | 3005823819-2019-00013 |
Device Sequence Number | 1 |
Product Code |
MQP
|
UDI-Device Identifier | 00814386022293 |
UDI-Public | 00814386022293 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K181921 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
10/29/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
No Information
|
Device Model Number | UU041-01-1927 |
Device Catalogue Number | UU041-01-1927 |
Device Lot Number | U019367 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/03/2019
|
Initial Date FDA Received | 12/27/2019 |
Supplement Dates Manufacturer Received | 12/03/2019
|
Supplement Dates FDA Received | 10/29/2021
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/25/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 38 YR |
|
|