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

Model Number	MS1-5590S
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for investigation nor were x-rays provided to confirm the alleged event.Root cause cannot be confirmed at this time.
Event or Problem Description
Information was received that the rods were removed on (b)(6) 2020 after being implanted.As per the reporter, the rods would not provide additional distraction in-situ.
Additional Manufacturer Narrative
The reported failure mode was confirmed as the rods were not distracted, and they did not meet specifications.The cause of the jam may have been the bending force applied on the rods during the distraction sessions.The patient¿s daily activities and unique anatomical structure can influence the amount of force applied to the rod.A review of the device history records revealed no discrepancies related to this complaint.The rods were manufactured in accordance with the specified requirements and met all of the required quality inspections.
Event or Problem Description
See updated information in d4, h2, h3, h6 and h10.

• Brand Name: MAGEC SYSTEM
• Common Device Name: GROWING ROD SYSTEM - MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 10312034
• Report Number: 3006179046-2020-00350
• Device Sequence Number: 3209432
• Product Code: PGN
• UDI-Device Identifier: 00812258026318
• UDI-Public: 812258026318
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: MS1-5590S
• Device Lot Number: A170112-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 10 YR
• Patient Weight: 18