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

Model Number RA002-4545SL

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

A distributor reported that a patient's magec rod broke.The patient was implanted with dual magec rods in 2012.

Manufacturer Narrative

A distributor reported that a patient's magec rod broke.The patient was implanted with dual magec rods in 2012.The exact date of implantation was is unknown; this is not an unusual event for growing rod patients.A revision surgery was performed on (b)(6) 2014 to remove the alleged broken.The patient was implanted with a new magec rod, without incident.To date, the patient is doing fine and no negative outcomes have been noted.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.).An evaluation of the returned device is in process.A dhr review revealed that there were no deviations from the manufacturing process and that the device was released within specifications.The device involved in the alleged incident is a prior version of the device cleared under k140178 and is 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: 3825850
• MDR Text Key: 4501744
• Report Number: 3006179046-2014-00015
• 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,Followup
• Report Date: 04/21/2014

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 Expiration Date: 01/01/2013
• Device Model Number: RA002-4545SL
• Device Lot Number: 110124-004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2014
• Initial Date FDA Received: 05/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2011
• 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: 8 YR