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 Dislodged or Dislocated (2923)

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

Event Date 09/15/2014

Event Type  Injury  

Event Description

A representative reported that during a patient's magec rod distraction session, the patient's left magec rod appeared to have had separated at the distal end, after reviewing ultrasound images.

Manufacturer Narrative

The patient was initially implanted with dual magec rods on (b)(6) 2013.To date, the patient is doing well and is asymptomatic.The surgeon has not removed the device at this time as the patient's condition is stable.A dhr review revealed that there were no deviations from the manufacturing process and that the device was released within specifications.

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: 4183036
• MDR Text Key: 5026734
• Report Number: 3006179046-2014-00027
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 09/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/30/2015
• Device Model Number: RA002-5555SL
• Device Lot Number: A130222-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2013
• 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): Other
• Patient Age: 9 YR
• Patient Weight: 32