Brand Name | INVICTUS SPINAL FIXATION SYSTEM |
Type of Device | THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM |
Manufacturer (Section D) |
ALPHATEC SPINE INC |
5818 el camino real |
carlsbad, ca |
|
Manufacturer Contact |
richard
younger
|
5818 el camino real |
carlsbad, ca
|
4949286
|
|
MDR Report Key | 10479322 |
MDR Text Key | 207159852 |
Report Number | 2027467-2020-00037 |
Device Sequence Number | 1 |
Product Code |
NKB
|
UDI-Device Identifier | 00190376136110 |
UDI-Public | (01)00190376136110 |
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 |
08/07/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/01/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 15004-085-080 |
Device Catalogue Number | 15004-085-080 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 08/07/2020 |
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 | 11 YR |