Brand Name | MAGEC GENERATION 1.5 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 | 17004461 |
MDR Text Key | 315996693 |
Report Number | 3006179046-2023-00207 |
Device Sequence Number | 1 |
Product Code |
PGN
|
UDI-Device Identifier | 00856719002183 |
UDI-Public | 856719002183 |
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K171791 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Company Representative |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial |
Report Date |
05/23/2023 |
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 | RA002-4545SL |
Device Lot Number | A171221-03 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
05/05/2023
|
Initial Date FDA Received | 05/25/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/21/2017 |
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 Outcome(s) |
Required Intervention;
|
Patient Age | 4 YR |
Patient Sex | Male |