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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MAGEC SPINAL BRACING AND DISTRACTION SYSTEM; GROWING ROD SYSTEM-MAGNETIC ACTUATION
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NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MAGEC SPINAL BRACING AND DISTRACTION SYSTEM; GROWING ROD SYSTEM-MAGNETIC ACTUATION Back to Search Results
Model Number MS1-4590R, MS1-4590S
Device Problems Break (1069); Mechanics Altered (2984)
Patient Problem No Code Available (3191)
Event Type  Injury  
Event Description
It was alleged that the patient's right magec rod would not distract, and the left rod was damaged.The physician revised the two magec rods with new ones without incident.
 
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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
aliso viejo, CA 92656
MDR Report Key7470981
MDR Text Key106834197
Report Number3006179046-2018-00030
Device Sequence Number1
Product Code PGN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140613
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
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
Date FDA Received04/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Model NumberMS1-4590R, MS1-4590S
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
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 Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age11 YR
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