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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
Device Problem Defective Device (2588)
Patient Problem Failure of Implant (1924)
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned for investigation as it is in situ.Root cause is unknown at this time.
 
Event Description
Information was received that the patient has been put on a surgical waiting list for revision procedure.As per the reporter, a pin break was identified in the rod.There was no patient information provided.
 
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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 dr, suite 100
aliso viejo CA 92656
Manufacturer (Section G)
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
101 enterprise dr, suite 100
aliso viejo CA 92656
Manufacturer Contact
tiara rae
101 enterprise dr, suite 100
aliso viejo, CA 92656
MDR Report Key10492172
MDR Text Key206374298
Report Number3006179046-2020-00385
Device Sequence Number1
Product Code PGN
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K171791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 08/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/05/2020
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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