MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED MAGEC GENERATION 2B MODIFIED SPINAL BRACING AND DISTRACTION SYSTEM; GROWING ROD SYSTEM - MAGNETIC ACTUATION

Model Number	MC2-5590S
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that one of the implanted rods failed to lengthen so both rods were removed.There is no additional information available.
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
Additional Manufacturer Narrative
The device was not returned for evaluation as it was lost during transit.The customer reported that one of the implanted rods failed to lengthen, resulting in the removal of both rods.Although physical evaluation was not possible, radiographic images provided by the customer were reviewed.Based on the images, one rod appears to have distracted approximately 9.5¿12 mm, while the other shows no evidence of distraction.Both rods exhibit intact and properly assembled end caps.Due to the limited clarity of the images, it was not possible to assess for potential internal component assembly issues.Consequently, the root cause of the reported failure could not be definitively determined.A review of the dhr documents indicates the device was manufactured by the specified requirement at the time and met all the required inspections upon release to finished goods.
Event or Problem Description
No additional information has been provided.

• Brand Name: MAGEC GENERATION 2B MODIFIED 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
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise suite 100; aliso viejo CA 92656
• Manufacturer Contact: whitney ginter ; 101 enterprise suite 100; aliso viejo, CA 92656 ; 8582005905
• MDR Report Key: 20516591
• Report Number: 3006179046-2024-00179
• Device Sequence Number: 21035384
• Product Code: PGN
• UDI-Device Identifier: 00812258022662
• UDI-Public: 812258022662
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

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: MC2-5590S
• Device Lot Number: 3033014AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Sex: Female