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

Model Number	MC2-5090S
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Codes	Failure of Implant (1924); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
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
Information was received that the rod did not fully achieve the desired distraction increments during lengthening sessions.X-rays revealed the right rod had a magnet fracture and a broken pin.The device was removed for final fusion.Additionally, it was reported that there was organic matter buildup around the rod and tissue discoloration.No patient adverse reaction or impact was reported.
Additional Manufacturer Narrative
During visual inspection, score marks consistent with expected markings due to incremental distraction were observed on the distraction rod.There was no visible cellulose buildup was found.The rod was functionally tested and unable to be distracted with manual distractor and electronic remote controller (erc).The rod was unable to be retracted with fast distractor to perform the stroke test.X-ray images of the internal components for the rod revealed broken internal parts such as; radial ball bearing, locking pin, retaining ring, anti-jam ring, and cylinder magnet.Sectioning of the housing tube revealed similar findings of the x-ray images.The radial ball bearing, locking pin, retaining ring, anti-jam ring and cylinder magnet were all broken.The reported failure mode was confirmed as the rod was not able to be distracted/retracted.There was no objective evidence to support the complaint description of tissue discoloration and cellulose buildup.After following up with the complaint reporter, no pictures or lab results were provided to support the complaint description of tissue discoloration and cellulose buildup.The iqc inspection data for the internal components; radial ball bearing, locking pin, retaining ring, anti-jam ring, and cylinder magnet were reviewed and the parts met design specifications per the engineering drawings.Review of the device history records revealed no discrepancies related to this complaint.The rod was manufactured in accordance with the specified requirements and met all of the required quality inspections.Based off the evidence seen from sectioning of the housing tube and the x-ray images of the rod, it can be deduced that the rod experienced repeated, excessive axial loading that caused serial failures of the various components that limit axial motion of the internal mechanism.
Event or Problem Description
No additional information was provided.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Common Device Name: GROWING ROD SYSTEM - MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise #100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise #100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise #100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 13182298
• Report Number: 3006179046-2022-00107
• Device Sequence Number: 2174958
• Product Code: PGN
• UDI-Device Identifier: 00887517834041
• UDI-Public: 887517834041
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• 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): 03/16/2022

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: MC2-5090S
• Device Lot Number: 8071101
• 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: 12/13/2021
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2018
• 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 Age: 12 YR
• Patient Sex: Female
• Patient Weight: 32 KG