MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED MAGEC GENERATION 1.5 SPINAL BRACING AND DISTRACTION SYSTEM; GROWING ROD SYSTEM - MAGNETIC ACTUATION

Model Number	RA002-5555SL
Medical Device Problem Codes	Failure to Advance (2524); Failure to Seal (4070)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to (b)(6); 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.The rod was disassembled and it was found that the leadscrew was seized inside the extending bar.The o-ring was snapped, consequently, it may have been unable to seal effectively.The compromised sealing mechanism may allow passage of fluid and material between the rod internals and the localised tissues, which can result in metallosis.It is unknown why the rod was removed.No additional information is available.
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 1.5 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: patrick yrigoyen ; 101 enterprise suite 100; aliso viejo, CA 92656 ; 8583442667
• MDR Report Key: 19983341
• Report Number: 3006179046-2024-00171
• Device Sequence Number: 15547267
• Product Code: PGN
• UDI-Device Identifier: 00856719002190
• UDI-Public: 856719002190
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 12/11/2024

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: RA002-5555SL
• Device Lot Number: 0021725
• 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
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2020
• 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 Sex: Unknown