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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 RA002-5555SL
Device Problem Mechanical Problem (1384)
Patient Problem Failure of Implant (1924)
Event Type  malfunction  
Manufacturer Narrative
No product has been returned for evaluation.Evaluation was performed by (b)(6).If additional relevant information is obtained, then a follow-up mdr will be submitted.
 
Event Description
It was reported that a revision procedure was performed for an unknown reason.During a review of investigation findings from lirc it was identified that the rod had evidence of pin fracture, galling, corrosion, and a broken radial bearing.Additionally it was reported that the rod was unable to be retracted.
 
Event Description
Na.
 
Event Description
No additional information.
 
Manufacturer Narrative
Additional information: no product has been returned for evaluation, however, investigation of the failure revealed that corrosion, surface finish and bending stresses all contribute to pin breaking.A new pin was implemented that had 65% improved strength and significantly improved corrosion resistance.
 
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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 #100
aliso viejo CA 92656
MDR Report Key12130008
MDR Text Key260534322
Report Number3006179046-2021-00353
Device Sequence Number1
Product Code PGN
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,other
Type of Report Initial,Followup,Followup
Report Date 07/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberRA002-5555SL
Device Lot NumberA140604-05
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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