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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 RA002-4545SLR70
Medical Device Problem Code Defective Device (2588)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 01/08/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation.Evaluation was performed by london implant retrieval center (lirc).
 
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2019 for an unknown reason.As per the reporter during service it was identified that there was clinical cold welding and debris in housing tube.
 
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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 Key9951920
Report Number3006179046-2020-00244
Device Sequence Number2900695
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 Explanted Year2019
Reporter Type Manufacturer
Report Source consumer,foreign,health profe
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial
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 NumberRA002-4545SLR70
Device Lot NumberA150415-11
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 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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