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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 RA002-4545SL
Device Problem Defective Device (2588)
Patient Problem Failure of Implant (1924)
Event Date 10/27/2017
Event Type  Injury  
Manufacturer Narrative
Device yet to be returned.
 
Event Description
It was reported that allegedly the patient's magec rod that was implanted in the right side was no longer lengthening.The physician performed a regular stabilization (b)(6) 2018.
 
Manufacturer Narrative
The rod was received for functional and visual testing and the reported event confirmed.The root cause of the reported event may be related to bending force applied during the distraction sessions and/or patient's daily activities.
 
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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 Key8384419
MDR Text Key137705910
Report Number3006179046-2019-00104
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,health
Type of Report Initial,Followup
Report Date 04/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberRA002-4545SL
Device Catalogue NumberPA0237
Device Lot NumberA120813-01
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/30/2019
Initial Date FDA Received03/02/2019
Supplement Dates Manufacturer Received04/28/2020
Supplement Dates FDA Received04/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age11 YR
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