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

Model Number MS1-45490S

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

A surgeon alleged that a patient's magec rod appeared to have had separated at the distal portion of the rod, where the device was contoured at the time of the initial implantation.The patient was implanted with dual magec rods for approximately ten (10) months prior to the alleged incident.

Manufacturer Narrative

The magec rod was removed and the patient was implanted with a new magec rod, without incident.It was reported that the patient was "actively climbing/jumping" on playground equipment, which may have contributed to the alleged incident.An initial visual inspection of the device revealed that the rod appeared to have had separated at a solid section of the end cap portion.To date, the patient is doing fine and continuing their treatment with magec; no negative outcomes have been reported.Dhr review revealed 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.).

• 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: 4770300
• MDR Text Key: 5949187
• Report Number: 3006179046-2015-00015
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/13/2015

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: 09/30/2014
• Device Model Number: MS1-45490S
• Device Lot Number: A140401-02-00-04U
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2015
• Initial Date FDA Received: 05/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• 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