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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 MC2-5090S
Device Problem Defective Device (2588)
Patient Problem Failure of Implant (1924)
Event Date 09/26/2019
Event Type  malfunction  
Manufacturer Narrative
The product was returned to the manufacturer and the device evaluation findings are not yet available.No x-rays or ultrasound images provided to confirm the alleged event.No root cause can be confirmed at this time.
 
Event Description
Information was received that a revision surgery was performed on (b)(6) 2019.As per the reporter, the rods were not distracting postoperative.
 
Manufacturer Narrative
Product was returned and customers alleged event was confirmed.Potential root cause may be related to bending force applied during the distraction sessions and or patients daily activities and unique anatomical structure.
 
Event Description
Investigation findings have been added to report and lot number has been updated.
 
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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 Key9246249
MDR Text Key164119260
Report Number3006179046-2019-00169
Device Sequence Number1
Product Code PGN
UDI-Device Identifier00887517834041
UDI-Public887517834041
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 06/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMC2-5090S
Device Lot NumberA160519-02
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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