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

Model Number RA002-4545SL

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

A surgeon alleged that a patient's magec rod appeared to have had separated near the actuator portion of the device after approximately three (3) months of implantation.

Manufacturer Narrative

The magec rod was removed and the patient was implanted with a new magec rod, without incident.No negative outcomes have been noted.To date, the patient is doing well and continuing with their treatment.The device has yet to be returned; therefore, no evaluation can be conducted at this time.A dhr review revealed that there were no deviations from the manufacturing process and that the device 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.).

Manufacturer Narrative

The device 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.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: GROWING ROD SYSTEM- MAGNETIC ACTUATION
• Manufacturer (Section D): ELLIPSE TECHNOLOGIES, INC.; 13900 alton parkway; suite 123; irvine CA 92618
• Manufacturer (Section G): ELLIPSE TECHNOLOGIES, INC.; 13900 alton parkway; suite 123; irvine CA 92618
• Manufacturer Contact: john mcintyre ; 13900 alton parkway; suite 123; irvine, CA 92618 ; 9498373600
• MDR Report Key: 4367807
• MDR Text Key: 5233562
• Report Number: 3006179046-2014-00033
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K140178
• 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,Followup
• Report Date: 11/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/01/2016
• Device Model Number: RA002-4545SL
• Device Lot Number: A140122-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2014
• 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; Other