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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 MC2-4570R
Medical Device Problem Code No Apparent Adverse Event (3189)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 03/06/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation as it was returned to the (b)(6).Root cause is unable to be determined.The reported event has been addressed in the device labeling.
 
Event or Problem Description
It was reported that a revision procedure was performed on (b)(6) 2020 for a final fusion.There was no patient injury reported.During a review of investigation findings from (b)(6) the rod failed to distract.
 
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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 Key11098820
Report Number3006179046-2020-00535
Device Sequence Number19042039
Product Code PGN
UDI-Device Identifier00812258022617
UDI-Public812258022617
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K171791
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date (Section B) 12/30/2020
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 NumberMC2-4570R
Device Lot Number8062301
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 12/07/2020
Initial Report FDA Received Date12/30/2020
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 Hospitalization;
Patient Age11 YR
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