Brand Name | UCENTUM |
Type of Device | PEDICLE SCREW |
Manufacturer (Section D) |
ULRICH GMBH & CO. KG |
buchbrunnenweg 12 |
ulm, baden-württemberg 89081 |
GM 89081 |
|
Manufacturer (Section G) |
ULRICH GMBH & CO. KG |
buchbrunnenweg 12 |
na |
ulm, baden-württemberg 89081 |
GM
89081
|
|
Manufacturer Contact |
christoph
ulrich
|
buchbrunnenweg 12 |
na |
ulm, baden-württemberg 89081
|
GM
89081
|
|
MDR Report Key | 8197766 |
MDR Text Key | 131442328 |
Report Number | 9612420-2018-00020 |
Device Sequence Number | 1 |
Product Code |
NKB
|
UDI-Device Identifier | 04052536078844 |
UDI-Public | 4052536078844 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K123717 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/12/2018,12/26/2018 |
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 |
Health Professional
|
Device Model Number | CS 3802-065-050 |
Device Catalogue Number | CS 3802-065-050 |
Device Lot Number | U0000888 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/13/2018 |
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 11/29/2018 |
Date Report to Manufacturer | 12/12/2018 |
Initial Date Manufacturer Received |
12/12/2018 |
Initial Date FDA Received | 12/26/2018 |
Was Device Evaluated by Manufacturer? |
No
|
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) |
Hospitalization;
|
Patient Age | 69 YR |
|
|