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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 MC2-5090S
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code Failure of Implant (1924)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device was returned to the (b)(4) for evaluation.Root cause is unable to be determined.
 
Event or Problem Description
It was reported that a revision procedure was performed on (b)(6) 2020.As per the reporter the rod was not lengthening.During a review of investigation findings from lirc it was identified that there was no device problem.
 
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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 Key11397093
Report Number3006179046-2021-00157
Device Sequence Number3372650
Product Code PGN
UDI-Device Identifier00887517834041
UDI-Public887517834041
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
Serviced by Third Party (Y/N)Y
Reporter Type Manufacturer
Report Source foreign,other
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date (Section B) 03/01/2021
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 NumberMC2-5090S
Device Lot Number7102419
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 02/05/2021
Initial Report FDA Received Date03/01/2021
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;
Patient Age10 YR
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