MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED MAGEC GENERATION 2B SPINAL BRACING AND DISTRACTION SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	MC2-5570S
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to newcastle university; no product was returned to the manufacturer for investigation.A root cause was unable to be determined with the information provided.
Event or Problem Description
An investigation report from an implant retrieval center was received and reported that during examination, the rod failed force testing.Additionally, the end cap was seized and unable to be removed.The rod was disassembled and the outer races, cage, and the rolling elements were heavily contaminated with grey, moist debris.The outer casing was seized within the outer casing, magnet, radial bearing, lead screw, extending bar, and outer casing.No further disassembly was possible, so the drive pin or other internal components were unable to be analyzed.It is unknown why the rod was removed.No additional information is available.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
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 SPINAL BRACING AND DISTRACTION SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: patrick yrigoyen ; 101 enterprise suite 100; aliso viejo, CA 92656 ; 8583442667
• MDR Report Key: 19977384
• Report Number: 3006179046-2024-00166
• Device Sequence Number: 7048163
• Product Code: PGN
• UDI-Device Identifier: 00812258022648
• UDI-Public: 812258022648
• 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: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2024

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: MC2-5570S
• Device Lot Number: 8062718
• 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: 07/23/2024
• Supplement Date Received by Manufacturer: 11/19/2024; 12/13/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 12/13/2024; 12/13/2024
• Date Device Manufactured: 06/21/2018
• 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 Sex: Unknown