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

Model Number RA002-5555SL

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Upon reviewing x-ray results, a doctor alleged that a patient's magec rod appeared to be broken; the patient had been implanted with the magec rod for almost two (2) years prior to the alleged breakage.

Manufacturer Narrative

This is not an unusual event for growing rod patients.The magec rod was removed on (b)(6) 2014.No negative outcomes have been reported.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.).To date, the device involved in the alleged incident has not been returned; therefore, no evaluation can be conducted.A dhr review revealed that there were no deviations from the manufacturing process and that the device was released within specifications.

• 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: 3760095
• MDR Text Key: 4419011
• Report Number: 3006179046-2014-00009
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K140178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/01/2013
• Device Model Number: RA002-5555SL
• Device Lot Number: 111115006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2011
• 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
• Patient Age: 10 YR