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

Model Number RA002-5555SL

Device Problem Activation Failure (3270)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

A distributor alleged that after reviewing x-rays results, a patient's right rod did not distract after their lengthening session.The patient has been implanted with dual magec rods for over one year.

Manufacturer Narrative

A distributor alleged that after reviewing x-rays results, a patient's right rod did not distract after their lengthening session.The patient was implanted with dual magec rods over one (1) year ago.The devices are still implanted in the patient.At this time, the surgeon reported that the right magec rod will not be removed as the patient's condition is stable.No negative outcomes have been reported; the patient is asymptomatic and is doing fine.The device has not been returned; therefore, no evaluation can be conducted.A dhr review of the device 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: 3831030
• MDR Text Key: 4392693
• Report Number: 3006179046-2014-00012
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/01/2014
• Device Model Number: RA002-5555SL
• Device Lot Number: A120625-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2012
• 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): Other
• Patient Age: 12 YR
• Patient Weight: 39