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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 RA002-5555SL
Device Problem Defective Device (2588)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
No product has been returned for investigation nor were x-ray films provided that confirm the alleged event.No root cause can be identified at this time.Labeling review: warning: ".Metallic implants can loosen, fracture, corrode, migrate, or cause pain." no product returned.
 
Event Description
As per reporter rods were no longer distracting and patient underwent a revision procedure.
 
Manufacturer Narrative
The rods were received for functional and visual testing and the reported event was 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 Key8956962
MDR Text Key156388145
Report Number3006179046-2019-00151
Device Sequence Number1
Product Code PNG
UDI-Device Identifier00856719002190
UDI-Public856719002190
Combination Product (y/n)N
PMA/PMN Number
K171791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 11/20/2019
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? Yes
Device Operator Health Professional
Device Model NumberRA002-5555SL
Device Lot Number1112158-010
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/07/2019
Initial Date FDA Received09/03/2019
Supplement Dates Manufacturer Received11/20/2019
Supplement Dates FDA Received11/26/2019
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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