Brand Name | MOMENTUM |
Type of Device | SCREWDRIVER FOR POLYAXIAL SCREW |
Manufacturer (Section D) |
ULRICH MEDICAL USA |
18221 edison ave. |
chesterfield MO 63005 |
|
Manufacturer (Section G) |
ULRICH GMBH & CO. KG |
buchbrunnenweg 12 |
|
ulm, baden-wurttemberg 89081 |
GM
89081
|
|
Manufacturer Contact |
louis
milos
|
18221 edison ave. |
chesterfield, MO 63005
|
|
MDR Report Key | 14337031 |
MDR Text Key | 291818879 |
Report Number | 3005823819-2022-00013 |
Device Sequence Number | 1 |
Product Code |
NKB
|
UDI-Device Identifier | 00814386025010 |
UDI-Public | 00814386025010 |
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,Followup |
Report Date |
07/25/2022 |
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 | UU052-30-0100 |
Device Catalogue Number | UU052-30-0100 |
Device Lot Number | U025561 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Initial Date Manufacturer Received |
04/11/2022 |
Initial Date FDA Received | 05/09/2022 |
Supplement Dates Manufacturer Received | 04/11/2022
|
Supplement Dates FDA Received | 07/25/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/18/2019 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
|
Patient Sex | Female |