MAUDE Adverse Event Report: NUVASIVE ORTHOPEDICS, INC. MAGEC SYSTEM; GROWING ROD SYSTEM - MAGNETIC ACTUATION

Model Number	MC2-5590R
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation nor x-rays to confirm the alleged event.Root cause is unavailable to be determined at this time.
Event or Problem Description
As per reporter the first x-ray (prior to 1st distraction) x-ray indicated a loosening of the endcap.First distraction went well, no revision procedure is planned at this time.

• Brand Name: MAGEC SYSTEM
• Common Device Name: GROWING ROD SYSTEM - MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE ORTHOPEDICS, INC.; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 10255596
• Report Number: 2031966-2020-00143
• Device Sequence Number: 14148205
• Product Code: PGN
• UDI-Device Identifier: 00812258022679
• UDI-Public: 812258022679
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/08/2020

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 Number: MC2-5590R
• Device Lot Number: 9012204AAA
• 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: 06/17/2020
• Initial Report FDA Received Date: 07/09/2020
• Patient Sequence Number: 1