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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED MAGEC SPINAL BRACING AND DISTRACTION SYSTEM; GROWING ROD SYSTEM-MAGNETIC ACTUATION
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NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED MAGEC SPINAL BRACING AND DISTRACTION SYSTEM; GROWING ROD SYSTEM-MAGNETIC ACTUATION Back to Search Results
Model Number RA002-4545SLR
Device Problem Defective Device (2588)
Patient Problem Failure of Implant (1924)
Event Date 05/28/2019
Event Type  malfunction  
Manufacturer Narrative
No product has been returned for evaluation.Evaluation was performed by (b)(4).Device returned to (b)(4).
 
Event Description
Information was received that a revision procedure was performed on (b)(6) 2019 for an unknown reason.As per the reporter during service it was identified that the drive pin was broken.There was no patient harm reported.
 
Event Description
Information was received that a revision procedure was performed on (b)(6), 2019 for an unknown reason.As per the reporter during service it was identified that the drive pin was broken.There was no patient harm reported.
 
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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, INCORPORATED
101 enterprise
suite 100
aliso viejo CA 92656
MDR Report Key10016419
MDR Text Key189742402
Report Number3006179046-2020-00300
Device Sequence Number1
Product Code PGN
UDI-Device Identifier00856719002138
UDI-Public856719002138
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,foreig
Type of Report Initial,Followup
Report Date 10/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberRA002-4545SLR
Device Lot NumberA140709-06
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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