Brand Name | REVERE |
Type of Device | 6.5MM REVERE PEDICLE SCREW, 40MM |
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 | 18837543 |
MDR Text Key | 337800876 |
Report Number | 3004142400-2023-00108 |
Device Sequence Number | 1 |
Product Code |
MNH
|
UDI-Device Identifier | 00849044001235 |
UDI-Public | 00849044001235 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K061202 |
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 |
03/04/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/05/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 124.464 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 07/11/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 | 43 YR |
Patient Sex | Female |
Patient Race | White |