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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 MC2-4590S
Device Problem Separation Problem (4043)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/21/2019
Event Type  malfunction  
Manufacturer Narrative
Remains implanted.
 
Event Description
It is reported that allegedly the cap has disengaged from the actuator allowing fluid and debris to get in/get out of the magec rod.Surgeon's anticipated course of action to replace the magec rod.
 
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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
aliso viejo CA 92656
Manufacturer Contact
claudia alvarez
101 enterprise, suite 100
aliso viejo, CA 92656
MDR Report Key8844180
MDR Text Key167992088
Report Number3006179046-2019-00119
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 health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 07/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMC2-4590S
Device Catalogue NumberPA0684-001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/01/2019
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 Number1
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