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

Model Number MS1-4590S

Device Problems Fracture (1260); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2022

Event Type  malfunction  

Manufacturer Narrative

Visual inspection revealed that the returned rod was partially distracted with wear and score marks consistent with expected markings due to incremental distraction of the distraction rod, and indicated it was extended approximately 3mm from its initial position.X-rays taken of the returned rod's internal components showed a broken radial ball bearing.The rod was functionally tested and was unable to distract or retract with the manual distractor as well as the external remote controller (erc).The rod was therefore determined to be jammed.Sectioning of the rod confirmed the radial bearing breakage and determined that the distraction rod could not be separated from the housing tube without use of high force, which equates with the distraction rod being out of alignment.It is possible bending forces applied to the rod from patient anatomy/activity may have caused the distraction rod to wedge into the housing tube/be out of alignment, leading to the broken radial bearing.A review of the device history records revealed no discrepancies during the manufacturing of the rods.The rods were manufactured in accordance with specified requirements and met all required quality inspections prior to shipment.Label review: contraindications: ".Patients and/or families unwilling or incapable of following postoperative care instructions." ".Correct selection of the appropriate implant size and correct placement of the device are essential to ensure optimal performance and function of the device." ".Metallic implants can loosen, fracture, corrode, migrate, or cause pain." ".During period of implant, patient should not participate in contact or severe sports or other high risk activities." ".During the implantation period, the patient should limit their backpack weight to 20 lbs.(9 kg) or less.".

Event Description

During evaluation of a returned rod, it was found the rod exhibited a broken radial bearing and would not distract.Initially, the rod was returned without a reported problem after it had been explanted as part of a planned removal for final fusion.There was no patient injury or adverse event associated with this device.No additional information is available.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: 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: 14734781
• MDR Text Key: 302445433
• Report Number: 3006179046-2022-00206
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00812258026295
• UDI-Public: 812258026295
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/17/2022

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
• Device Operator: Health Professional
• Device Model Number: MS1-4590S
• Device Lot Number: 00823403AAB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2022
• Initial Date FDA Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Sex: Female
• Patient Weight: 41 KG