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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 RA002-5555SLR70
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Type  Injury  
Event Description
It was alleged that one of the patient's magec rods was damaged.The physician revised the rods with new magec rods without incident.
 
Manufacturer Narrative
A visual inspection of the returned rod revealed that the rod was partially distracted with score marks on the distraction rod.The rod could be lengthened by hand when pulling on the distraction rod, which confirms the pin failures.A review of the lot history record for the device revealed that the device met all of the required quality inspections and that the products were released within specifications.
 
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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
MDR Report Key7527972
MDR Text Key108728671
Report Number3006179046-2018-00038
Device Sequence Number1
Product Code PGN
Combination Product (y/n)N
PMA/PMN Number
K140613
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 04/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Model NumberRA002-5555SLR70
Device Catalogue NumberPA0474
Device Lot NumberA140929-04
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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