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

Model Number	MC2-4590S
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that a pair of rods were implanted and the left side rod's end cap disassociated.Per the reporter, the rod continued to lengthen despite the end cap issue.It was additionally reported that during the planned removal procedure there was significant metallosis observed visually.No samples were taken to confirm the metallosis.
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.Lot numbers 9080301 and 9061819 were provided, however, it is unknown which lot number corresponds to the rod in question.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
No additional information was provided.
Event or Problem Description
Additional information was provided.
Additional Manufacturer Narrative
Upon receiving the device, a visual inspection was conducted.It was noted that the end cap was unthreaded.The reported issue of end cap disengagement was confirmed.There was also notable anodization wear along the anti-rotation sleeve.In-house x-rays were conducted and showed that the internal components were still intact except for the end cap and anti-rotation sleeve.Functional testing was attempted, however, was not successful due to the to the sleeve being disengaged.There were no images provided to review the perceived metallosis so it was unable to be confirmed.This lot was manufactured prior to the capa which was issued to rectify this issue and resulted in a design change.

• Brand Name: MAGEC GENERATION 2B SPINAL BRACING AND DISTRACTION SYSTEM
• Common Device Name: GROWING ROD SYSTEM - MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr. ste 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr. ste 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr. ste 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 18520247
• Report Number: 3006179046-2024-00100
• Device Sequence Number: 15122402
• Product Code: PGN
• UDI-Device Identifier: 00812258022624
• UDI-Public: 812258022624
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2024

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 Number: MC2-4590S
• Device Lot Number: 9061819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/22/2023
• Supplement Date Received by Manufacturer: 03/22/2024; 03/23/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 03/23/2024; 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Weight: 32 KG