Brand Name | INVICUS |
Type of Device | THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM |
Manufacturer (Section D) |
ALPHATEC SPINE, INC. |
1950 camino vida roble |
carlsbad CA 92008 |
|
Manufacturer (Section G) |
ALPHATEC SPINE, INC. |
1950 camino vida roble |
|
carlsbad CA 92008 |
|
Manufacturer Contact |
wesley
channell
|
1950 camino vida roble |
carlsbad, CA 92008
|
9014283693
|
|
MDR Report Key | 18924420 |
MDR Text Key | 337910486 |
Report Number | 2027467-2024-00030 |
Device Sequence Number | 1 |
Product Code |
NKB
|
UDI-Device Identifier | 00190376137902 |
UDI-Public | (01)00190376137902(10)SM153271 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K181677 |
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 |
03/18/2024 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 15100 |
Device Catalogue Number | 15100 |
Device Lot Number | SM153271 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/04/2024 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 03/18/2024 |
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) |
Required Intervention;
|