Brand Name | MOMENTUM |
Type of Device | SCREW, POLYAXIAL, 6.5MM DIAMETER, LENGTH 45MM, NON CANULATED |
Manufacturer (Section D) |
ULRICH MEDICAL USA |
3700 east plano parkway |
suite 200 |
plano 75074 |
|
Manufacturer (Section G) |
ULRICH GMBH & CO. KG |
buchbrunnenweg 12 |
|
ulm, baden-wurttemberg 89081 |
GM
89081
|
|
Manufacturer Contact |
louis
milos
|
3700 east plano parkway |
suite 200 |
plano, TX 75074
|
4692380832
|
|
MDR Report Key | 18150555 |
MDR Text Key | 328302863 |
Report Number | 3005823819-2023-00011 |
Device Sequence Number | 1 |
Product Code |
NKB
|
UDI-Device Identifier | 00814386022873 |
UDI-Public | 00814386022873 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K191932 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
11/15/2023 |
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 | UU051-00-6545 |
Device Catalogue Number | UU051-00-6545 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
10/23/2023
|
Initial Date FDA Received | 11/16/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
Patient Outcome(s) |
Hospitalization;
|
Patient Age | 50 YR |
|
|