MAUDE Adverse Event Report: NUVASIVE, INC. MAGEC MAGNETIC GROWING RODS; GROWING ROD SYSTEM - MAGNETIC ACTUATOR

Model Number MC2-4590S

Device Problems Migration or Expulsion of Device (1395); Naturally Worn (2988)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/21/2019

Event Type  Injury  

Event Description

Magnetic growing rods were implanted (b)(6) 2018 without complication.Rods have subsequently been lengthened in the clinic without difficulty using the external remote controller.On (b)(6) 2019, an abnormality was noted on ultrasound and x-ray.The rods lengthened normally.Surgeon discussed with the company; they describe that it is consistent with an "endcap migration" from the actuator.They have seen this one other time.The endcap appears to be a ring and is constrained by the rod and not free floating.The concern is that this may lead to greater degree of titanium wear particles being released - unk health affects also may lead to premature cessation of magnetic lengthening function.The mfr recommended considering replacing the magnetic rod.Fda safety report id# (b)(4).

• Brand Name: MAGEC MAGNETIC GROWING RODS
• Type of Device: GROWING ROD SYSTEM - MAGNETIC ACTUATOR
• Manufacturer (Section D): NUVASIVE, INC.
• MDR Report Key: 8790684
• MDR Text Key: 151204001
• Report Number: MW5088102
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/09/2019

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: MC2-4590S
• Device Catalogue Number: MC2-4590S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR