Brand Name | MAGEC SPINAL BRACING AND DISTRACTION SYSTEM |
Type of Device | GROWING ROD SYSTEM-MAGNETIC ACTUATION |
Manufacturer (Section D) |
NUVASIVE SPECIALIZED ORTHOPEDICS, INC. |
101 enterprise suite 100 |
aliso viejo CA 92656 |
|
Manufacturer (Section G) |
NUVASIVE SPECIALIZED ORTHOPEDICS, INC. |
101 enterprise, suite 100 |
|
aliso viejo CA 92656 |
|
Manufacturer Contact |
claudia
alvarez
|
101 enterprise suite 100 |
aliso viejo, CA 92656
|
|
MDR Report Key | 8881270 |
MDR Text Key | 153955800 |
Report Number | 3006179046-2019-00132 |
Device Sequence Number | 1 |
Product Code |
PGN
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K140613 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
08/09/2019 |
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? |
No
|
Device Operator |
Health Professional
|
Device Model Number | RA002-5555SL |
Device Catalogue Number | PA0239 |
Device Lot Number | 110112-007-006, 110405-002 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
07/11/2019
|
Initial Date FDA Received | 08/09/2019 |
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) |
Hospitalization;
Required Intervention;
|
Patient Age | 4 YR |