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 |
carol
bleakley
|
101 enterprise, suite 100 |
aliso viejo, CA 92656
|
|
MDR Report Key | 7471025 |
MDR Text Key | 106835353 |
Report Number | 3006179046-2018-00035 |
Device Sequence Number | 1 |
Product Code |
PGN
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K140613 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,health profession |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
03/28/2018 |
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 |
Physician
|
Device Lot Number | A150204-03 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/23/2018 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/28/2018
|
Initial Date FDA Received | 04/27/2018 |
Supplement Dates Manufacturer Received | 03/28/2018
|
Supplement Dates FDA Received | 06/07/2018
|
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 9 YR |