Brand Name | MAGEC GENERATION 2B SPINAL BRACING AND DISTRACTION SYSTEM |
Type of Device | GROWING ROD SYSTEM - MAGNETIC ACTUATION |
Manufacturer (Section D) |
NUVASIVE SPECIALIZED ORTHOPEDICS, INC. |
101 enterprise dr. ste 100 |
aliso viejo CA 92656 |
|
Manufacturer (Section G) |
NUVASIVE SPECIALIZED ORTHOPEDICS, INC. |
101 enterprise dr. ste 100 |
|
aliso viejo CA 92656 |
|
Manufacturer Contact |
geoff
gannon
|
101 enterprise dr. ste 100 |
aliso viejo, CA 92656
|
8583448112
|
|
MDR Report Key | 18807776 |
MDR Text Key | 336564560 |
Report Number | 3006179046-2024-00115 |
Device Sequence Number | 1 |
Product Code |
PGN
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K171791 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
04/15/2024 |
2 Devices were Involved in the Event: |
1
2
|
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 | MC2-5090S |
Device Lot Number | 7091602AAA |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
02/29/2024 |
Initial Date FDA Received | 02/29/2024 |
Supplement Dates Manufacturer Received | 02/29/2024 03/04/2024 04/12/2024
|
Supplement Dates FDA Received | 02/29/2024 03/04/2024 04/15/2024
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/15/2017 |
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 Age | 11 YR |
Patient Sex | Male |
Patient Weight | 29 KG |