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

Model Number RA002-5555SL AND RA002-5555SLR

Device Problem Insufficient Information (3190)

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

A distributor reported that a patient developed an infection after being implanted with dual magec rods.

Manufacturer Narrative

On (b)(4) 2014 a distributor reported that a patient experienced an infection after being implanted with dual magec rods.The patient was presented with fever, pain, and discharge from the infected area (surface of skin).Dual magec rods were implanted in the patient on (b)(6) 2010.Upon clarification from the distributor, it was reported that the patient developed an infection after each lengthening session; the patient was treated with antibiotics and the infection site (surface of the skin) was debrided each time.The surgeon removed the patient's magec rods on (b)(6) 2014 and treated the infection with antibiotics.No lot numbers were provided; an evaluation of the returned rods is anticipated, but has not yet begun.The devices involved in the alleged incident are prior versions of the device cleared under k140178 and are no longer commercially available in the us or ous.Out of an abundance of caution a report is being submitted with regard to the alleged serious injury.

• 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: 3831585
• MDR Text Key: 22263614
• Report Number: 3006179046-2014-00016
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 04/25/2014

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?: Yes
• Device Operator: Physician
• Device Model Number: RA002-5555SL AND RA002-5555SLR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/25/2014
• Initial Date FDA Received: 05/25/2014
• Was Device Evaluated by Manufacturer?: No
• 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; Other
• Patient Age: 6 YR