MAUDE Adverse Event Report: ELLIPSE TECHNOLOGIES, INC. MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM; GROWNING ROD SYSTEM-MAGNETIC ACTUATION

Model Number MS1-5590R

Device Problem Material Separation (1562)

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

Event Type  Injury  

Manufacturer Narrative

The patient was initially implanted with dual magec rods, and it was alleged the patient's right magec rod appeared to have separated at the solid section of the distraction rod, near the distal fixation site.The rod was removed, and the patient was implanted with a new magec rod, without incident.To date, the patient is doing fine and no negative outcomes have been reported.A dhr review confirmed that the device met all of the required quality inspections, and was released within specifications.This is not an unusual event for growing rod patients.In the literature, growing rods have been reported to break in approximately 25% of cases (bess s, et.Al., "complications of growing-rod treatment for early onset scoliosis: analysis of one hundred and forty patients", j bone joint surg am.2010; 92: 1-11.).

Event Description

A representative reported that a surgeon alleged that a patient's magec rod appeared to have separated at the solid section of the distraction rod near the distal fixation site.

• Brand Name: MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: GROWNING ROD SYSTEM-MAGNETIC ACTUATION
• Manufacturer (Section D): ELLIPSE TECHNOLOGIES, INC.; 101 enterprise; suite 100; aliso viejo CA 92656
• Manufacturer (Section G): ELLIPSE TECHNOLOGIES, INC.; 101 enterprise; suite 101; aliso viejo CA 92656
• Manufacturer Contact: john mcintyre ; 101 enterprise; suite 101; aliso viejo, CA 92656 ; 9498373600
• MDR Report Key: 5544958
• MDR Text Key: 241272468
• Report Number: 3006179046-2016-00005
• Device Sequence Number: 1
• Product Code: PGN
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/01/2017
• Device Model Number: MS1-5590R
• Device Lot Number: A150715-20-00-01U
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2015
• 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 Outcome(s): Hospitalization
• Patient Age: 8 YR