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

Model Number	RA002-5555SLR70
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that a revision procedure was performed for the removal the magec rod and conversion to a definitive fusion.As per the reporter, there were a lot of black stains in the tissue where the rods had been lengthening.There was no infection or necrosis.No additional information has been provided at this time.Report 2 of 2.
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.A review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
The unit has not been returned to the manufacturer for direct investigation.This investigation was performed based on provided intraoperative photographs.During evaluation of the provided intraoperative photographs, presence of possible black discolored tissue was observed along the location where the rod was placed which confirmed the reported tissue discoloration.The unit¿s work order was reviewed and confirmed that the device passed all quality inspections per the acceptance tests prior to shipment.The exact cause of the reported failure mode could not be determined due to the limited clinical information as well as no device return.

• Brand Name: MAGEC 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: 15106019
• Report Number: 3006179046-2022-00232
• Device Sequence Number: 17456677
• Product Code: PGN
• UDI-Device Identifier: 00856719002169
• UDI-Public: 856719002169
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K161751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: RA002-5555SLR70
• Device Lot Number: A161006-01
• 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: 07/07/2022
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2016
• 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 Age: 14 YR
• Patient Sex: Male
• Patient Weight: 50 KG