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 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 | 13614936 |
MDR Text Key | 290371232 |
Report Number | 3006179046-2022-00129 |
Device Sequence Number | 1 |
Product Code |
PGN
|
UDI-Device Identifier | 00812258026356 |
UDI-Public | 812258026356 |
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
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
02/25/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/26/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | MS1-5570S |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 02/01/2022 |
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 |
Treatment | DEPUY-4.2X25MM SCREW, LOT 0203 09DEC2019; DEPUY-5.2X30MM SCREW, LOT 0203 09DEC2019; DEPUY-5.2X40MM SCREW, LOT 0203 09DEC2019; DEPUY-COLLAR, LOT 0203 09DEC2019; DEPUY-DISTRACTION LOCK, 0206 01AUG2019; DEPUY-NUT, LOT 0203 09DEC2019; DEPUY-SIZE 6 220MM DISTAL EXTENSION; DEPUY-SIZE 6 220MM PROX. EXTENSION; DEPUY-SIZE 7 220MM DISTAL EXTENSION; DEPUY-SIZE 7 220MM PROX, EXTENSION |
Patient Outcome(s) |
Required Intervention;
|
Patient Sex | Female |
|
|