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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 MS1-5590S
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Type  Injury  
Event Description
It was reported that allegedly the patient's magec rod was damaged.The rod was revised with a new magec rod 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
101 enterprise, suite 100
aliso viejo, CA 92656
MDR Report Key7341860
MDR Text Key102512167
Report Number3006179046-2018-00016
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 distributor,health profession
Reporter Occupation Physician
Type of Report Initial
Report Date 02/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Model NumberMS1-5590S
Device Catalogue NumberPA0518
Device Lot NumberA140414-06
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/13/2018
Initial Date FDA Received03/15/2018
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
Patient Outcome(s) Hospitalization; Required Intervention;
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