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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED MAGEC® SYSTEM; GROWING ROD SYSTEM- MAGNETIC ACTUATION
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NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED MAGEC® SYSTEM; GROWING ROD SYSTEM- MAGNETIC ACTUATION Back to Search Results
Model Number RA002-5555SLR70
Medical Device Problem Code Defective Device (2588)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 12/06/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation.Evaluation was performed by (b)(6).
 
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2018 for an unknown reason.As per the reporter during service it was identified that there was a pin fracture and a large amount of debris in the housing tube.
 
Additional Manufacturer Narrative
Updated the country for the initial reporter.Corrected the name of the facility that the device was returned.H3 other text : device returned to lirc.
 
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Brand Name
MAGEC® SYSTEM
Common Device Name
GROWING ROD SYSTEM- MAGNETIC ACTUATION
Manufacturer (Section D)
NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED
101 enterprise
suite 100
aliso viejo CA 92656
MDR Report Key9951857
Report Number3006179046-2020-00224
Device Sequence Number14140768
Product Code PGN
UDI-Device Identifier00856719002169
UDI-Public856719002169
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K171791
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date (Section B) 04/12/2020
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
Operator of Device Health Professional
Device Model NumberRA002-5555SLR70
Device Lot NumberA140308-03
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 07/30/2019
Supplement Date Received by Manufacturer07/30/2019
Initial Report FDA Received Date04/12/2020
Supplement Report FDA Received Date04/12/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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