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

Model Number	MC2-5070S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that a revision procedure was performed as the contralateral side rod was no longer lengthening.Upon removal of the left rod it was noted that the two ends of the rod were moving independently.Additionally, it was reported that during the procedure the surgeon applied a lot of torque to the rod which may have resulted in a segment of the rod breaking off, therefore, the two ends had to be removed separately.
Additional Manufacturer Narrative
Device evaluation: the rod was returned to nuvasive for evaluation.Visual inspection was performed and revealed a crack on the housing body.The device was received in two pieces, therefore, functional testing was unable to be performed.The distraction rod was separated from the housing body and the threaded cap was mounted on the distraction rod.A portion of the lead screw was threaded flush to the end of the distraction rod and was unthreaded without issue from the distraction rod/tapered distraction nut.The distraction rod appeared to have reached near the maximum length based on the 8mm long portion of the lead screw removed from the distraction rod.The distraction distance would provide a greater moment arm (force) on the threaded cap, however, the order of what occurred is unknown and no clinical x-rays were provided.The fractured housing body and the fractured lead screw may have allowed the threaded cap and distraction rod to separate as a unit without the end cap unthreading.The rod may have separated because the threaded cap disengaged and the lead screw broke.The break may have been result of force placed on the rod during the removal procedure according to the provided information, however, the exact cause is unknown.A corrective and preventive action (capa) was implemented which addressed the unthreading and potential separation of the threaded cap from the housing body.The device was built prior to the implementation of the capa.Device record review: a review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.
Event or Problem Description
No additional information has been 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, 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: 16898066
• Report Number: 3006179046-2023-00196
• Device Sequence Number: 14843260
• Product Code: PGN
• UDI-Device Identifier: 00887517834027
• UDI-Public: 887517834027
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2023

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: MC2-5070S
• Device Lot Number: 9090608AAA
• 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: 04/18/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2019
• 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
• Patient Age: 12 YR
• Patient Sex: Male