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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 Break (1069)
Patient Problem Failure of Implant (1924)
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned for evaluation as it remains in-situ nor were x-rays provided to confirm the alleged event.Root cause is unable to be determined at this time.The reported event has been addressed in the device labeling.
 
Event Description
Information was received that a patient has a broken rod that needs to be replaced.At this time, the revision procedure has not been performed.
 
Manufacturer Narrative
Additional information was received that a revision procedure was performed on an unknown date.The rods will not be returned to the manufacturer for evaluation as they were discarded at the facility in which the revision occurred.
 
Event Description
N/a.
 
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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
MDR Report Key11098905
MDR Text Key224596553
Report Number3006179046-2020-00542
Device Sequence Number1
Product Code PGN
Combination Product (y/n)N
PMA/PMN Number
K171791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/07/2021
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
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/08/2020
Initial Date FDA Received12/30/2020
Supplement Dates Manufacturer Received04/07/2021
Supplement Dates FDA Received04/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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