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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE, INC MAGEC ROD SYSTEM; GROWING ROD SYSTEM-MAGNETIC ACTUATION
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NUVASIVE, INC MAGEC ROD SYSTEM; GROWING ROD SYSTEM-MAGNETIC ACTUATION Back to Search Results
Device Problem Unexpected Therapeutic Results (1631)
Patient Problem Failure of Implant (1924)
Event Date 11/15/2018
Event Type  Injury  
Event Description
My son had spinal rod implementation for correction of scoliosis in (b)(6) 2015 and again in (b)(6) 2018 with the magec rod system, made by the company nuvasive, and both rods malfunctioned.The rods are designed to lengthen with an external magnet in the physician¿s office regularly such as every 3 months.The purpose of lengthening is to allow the child¿s trunk (spine) to grow.The rods correct the scoliosis and the magnetic feature is to lengthen the rods.The first system failed and he had another surgery to replace the rods which malfunctioned immediately.By malfunctioning i am referring to the fact the rods were unable to lengthen which is the entire purpose of the product.Spinal rod surgery is an incredibly large serious surgery, painful recovery.My son will now require another surgery to remove the malfunctioning implanted rods.The magnetic rod device requires further investigation for failure as i know we are not the only patient in which the rods malfunctioned.
 
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Brand Name
MAGEC ROD SYSTEM
Type of Device
GROWING ROD SYSTEM-MAGNETIC ACTUATION
Manufacturer (Section D)
NUVASIVE, INC
MDR Report Key8359011
MDR Text Key137180962
Report NumberMW5084175
Device Sequence Number1
Product Code PGN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 02/15/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/19/2019
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age12 YR
Patient Weight36
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