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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 RA002-4545SLR70
Medical Device Problem Code Defective Device (2588)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 10/16/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device will be returned to (b)(6) for investigation.The device was not returned to the manufacturer for investigation.Root cause is unknown at this time.Device was returned to (b)(6).
 
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2018 for an unknown reason.During a review of investigation findings from (b)(6) it was identified that the rod had a pin fracture.
 
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Brand Name
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
Common Device Name
GROWING ROD SYSTEM - MAGNETIC ACTUATION
Manufacturer (Section D)
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
101 enterprise dr, suite 100
aliso viejo CA 92656
MDR Report Key10521938
Report Number3006179046-2020-00389
Device Sequence Number16923849
Product Code PGN
UDI-Device Identifier00856719002145
UDI-Public856719002145
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K171791
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date (Section B) 09/11/2020
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
Operator of Device Health Professional
Device Model NumberRA002-4545SLR70
Device Lot NumberA140127-09
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/30/2019
Initial Report FDA Received Date09/11/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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