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

Model Number RA002-5555SL

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

After almost one (1) year of implantation, a surgeon alleged that a patient's magec rod may not be functioning and was removed and replaced.

Manufacturer Narrative

The patient's magec rod was removed and replaced with a new magec rod.No negative outcomes were reported.A dhr review revealed that there were no deviations from the manufacturing process and that the device was released within specifications.To date, the device has not been returned; therefore, no evaluation can be conducted.

• 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: 4793454
• MDR Text Key: 5877235
• Report Number: 3006179046-2015-00018
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K140178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/01/2016
• Device Model Number: RA002-5555SL
• Device Lot Number: A140301-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2015
• Initial Date FDA Received: 05/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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