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	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and is pending evaluation.The root cause cannot be confirmed at this time.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that the right side rod fractured caudal to the right l2 pedicle screw.Additionally, it was reported that there was blackening of the tissue around the actuator.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
Device evaluation: upon receipt to nuvasive a visual inspection of the rod was conducted.It was visually confirmed that the rod was broken on the housing body side.It was also observed that the rod was partially distracted with deep scoring marks on the distraction rod.Functional testing was attempted but the rod would not distract.X-rays of the rod do not show any clear component failure, however, it was noted that there was uneven spacing between the distraction rod and housing tube.It is likely that the scoring was a result of the distraction rod rubbing against the threaded cap.For the threaded cap to score the distraction rod external bending force would need to be applied to the actuator.Due to these external bending forces, the distraction rod became scored.It is also possible that exposure to excessive or repeated loading resulted in an unstable construct.Therefore, it is unknown but likely that after implantation, patient activity or weight, could have exceeded loads of the device.Device record review: a review of the device history record (dhr) indicates the rod was manufactured to all specified requirements at the time and met all the required inspections prior to shipment.

• 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: 17398277
• Report Number: 3006179046-2023-00313
• Device Sequence Number: 12245173
• 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
• Report Date (Section B): 10/03/2023

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: MC2-4590S
• Device Lot Number: 8082309AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2023
• 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: 06/29/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2018
• 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: Male
• Patient Weight: 26 KG