Brand Name | CREO MIS STABILIZATION SYSTEM |
Type of Device | CREO MIS LOCKING CAP |
Manufacturer (Section D) |
GLOBUS MEDICAL, INC. |
2560 general armistead avenue |
audubon PA 19403 |
|
Manufacturer (Section G) |
GLOBUS MEDICAL, INC. |
2560 general armistead avenue |
|
audubon PA 19403 |
|
Manufacturer Contact |
daniel
paul
|
2560 general armistead avenue |
audubon, PA 19403
|
6109301800
|
|
MDR Report Key | 15360415 |
MDR Text Key | 302415468 |
Report Number | 3004142400-2022-00127 |
Device Sequence Number | 1 |
Product Code |
MNH
|
UDI-Device Identifier | 00889095071139 |
UDI-Public | 00889095071139 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K124058 |
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 |
08/29/2022 |
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 | 1134.0010 |
Device Lot Number | BAY653GC/BAA187WC/BAA053LC |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/15/2022 |
Initial Date Manufacturer Received |
08/09/2022 |
Initial Date FDA Received | 09/06/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/10/2021 |
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 | 58 YR |
Patient Sex | Male |
Patient Race | White |