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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 MC2-5570S
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 04/22/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No product will be returned for evaluation.Radiographs provided confirmed the alleged event.No root cause can be confirmed at this time.
 
Event or Problem Description
Information was received that a revision procedure was performed.As per the reporter, x-rays revealed that the end cap had disengaged.There is was no patient injury reported.
 
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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, INCORPORATED
101 enterprise
suite 100
aliso viejo CA 92656
MDR Report Key10076721
Report Number3006179046-2020-00313
Device Sequence Number19542054
Product Code PGN
UDI-Device Identifier00812258022648
UDI-Public812258022648
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K171791
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 01/25/2021
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 NumberMC2-5570S
Device Lot Number8121330AAA
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 04/22/2020
Supplement Date Received by Manufacturer01/19/2021
Initial Report FDA Received Date05/20/2020
Supplement Report FDA Received Date01/25/2021
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 Hospitalization;
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