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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  Injury  

Event Description

A surgeon alleged that a patient experienced a loss of distraction after being implanted with a single magec rod; the device was removed.

Manufacturer Narrative

The magec rod was removed, without incident.It was also reported that upon removal of the device, it appeared that the patient experienced a tissue reaction at the site of implantation.No further information was received with regard to the patient's health and no details surrounding the patient's procedure was provided.To date, the device involved in the alleged incident has not been returned and no lot number was provided; therefore, no investigation 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: 3907647
• MDR Text Key: 4492911
• Report Number: 3006179046-2014-00019
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K140178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/02/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2014
• Initial Date FDA Received: 07/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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