Brand Name | REVOLVE |
Type of Device | 5.5 MM REVOLVE POLYAXIAL PEDICLE SCREW, 45MM |
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 | 18809337 |
MDR Text Key | 336625345 |
Report Number | 3004142400-2016-00017 |
Device Sequence Number | 1 |
Product Code |
MNH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K083416 |
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 |
02/27/2024 |
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 | 185.455 |
Device Lot Number | BAS137EE |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/16/2018 |
Initial Date Manufacturer Received |
04/26/2016
|
Initial Date FDA Received | 02/29/2024 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/17/2015 |
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 | 59 YR |
Patient Sex | Male |
Patient Weight | 79 KG |