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

Model Number	MC2-5570S
Medical Device Problem Codes	Failure to Advance (2524); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that a revision procedure was performed due to the rod failing to distract.The revision surgery was completed with no issue or adverse consequences to the patient.
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 received for evaluation.Visual inspection was performed, and it was observed that the threaded cap had come undone.Both the endcap and distraction rod appeared covered in debris.Scoring was also observed on the distraction rod which corresponds with periodic distractions.No other markings were observed on the rod housing tube.In-house x-rays taken of the internal components confirmed the end cap disengagement and revealed the bearing was pushing on the retaining clip.Functional testing was attempted, however, it failed, confirming the failure to distract.To perform a thorough evaluation of the device, the rod was sectioned.It was observed that the inside of the housing tube was packed with debris.The image of the distraction rod showed a combination of rust coloring and black debris.It is highly likely that the black debris is titanium from distraction rod, and the rust could be from dried bodily fluids.It is also likely that the endcap disengagement could have contributed to the accumulation of debris inside the rod.This debris ultimately would have contributed to the failure to distract as the bearings encountered higher friction.The endcap disengagement failure mode was addressed under a capa.The capa investigation found that the torque that was being applied to thread the endcap was not effective as there was an interaction between the cap and the spline insert.This ultimately led to a design change that added a redundant feature, namely swaging the endcap after being threaded.A review of the dhr documents indicates that the device was manufactured by the specified requirement at the time and met all the required inspections before shipment.
Event or Problem Description
No additional information was provided.

• Brand Name: MAGEC GENERATION 2B 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: 19570393
• Report Number: 3006179046-2024-00137
• Device Sequence Number: 6974497
• Product Code: PGN
• UDI-Device Identifier: 00812258022648
• UDI-Public: 812258022648
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2024

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: MC2-5570S
• Device Lot Number: 9052209
• 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: 06/10/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 08/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2019
• 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 Sex: Unknown