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	Structural Problem (2506)
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 left side rod's o-ring was displaced in 2019.Additionally, it was reported that there was blackening of the tissue around the actuator.
Additional Manufacturer Narrative
Device evaluation: upon receipt to nuvasive a visual inspection of the rod was conducted.It was visually confirmed that the thread cap had disengaged from the housing body.It was also observed that the rod was partially distracted with some slight discoloration on the distraction rod which may be related to the reported blackening of the skin around the actuator.The blackened tissue was unable to be confirmed as no objective evidence was provided.No scoring marks or scratches were observed on the outer surface of the device.X-rays were taken of the rod and found that the retaining ring was out of the housing body groove.Per the risk file, if there is inadequate engagement between the retaining ring and the housing body groove that could potentially lead to a device failing to distract.This failure was observed when attempting to distract the rod with a fast distractor and no distraction could be achieved.The root cause is likely that the design was insufficient to prevent the threaded cap from separating.A corrective and preventive action (capa) was initiated to address the design failure.Based on the investigation conducted in the capa, the design was insufficient to prevent the cap from separating.Since this rod was manufactured prior to the implementation of this capa it is possible that the design was insufficient to prevent the separation that was reported.It should be noted that this rod was manufactured in 2019 prior to the implementation of the capa.Device record review: a review of the device history record (dhr) indicates the rod was manufactured by the specified requirement at the time and met all the required inspections before shipment.
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: 17398263
• Report Number: 3006179046-2023-00312
• Device Sequence Number: 17625098
• 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): 09/29/2023

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: 9011812AAA
• 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: 09/28/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2019
• 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 Sex: Male
• Patient Weight: 26 KG