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

Model Number RA002-5555SLR

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 10/07/2015

Event Type  Injury  

Manufacturer Narrative

The patient was initially implanted with dual magec rods on (b)(6) 2013.The patient's magec rod was removed on (b)(6) 2015 and replaced with a new magec rod, without incident.To date, the patient is doing well and no negative outcomes have been reported.A dhr review revealed that the device met all the required quality inspections and was released within specifications.

Event Description

A (b)(4) distributor reported that after over two (2) years of implantation a patient's magec rod was removed and replaced with a new magec rod; the rod allegedly did not appear to be functioning.

• Brand Name: MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: GROWING ROD SYSTEM-MAGNETIC ACTUATION
• Manufacturer (Section D): ELLIPSE TECHNOLOGIES, INC.; 101 enterprise; suite 100; aliso viejo CA 92656
• Manufacturer (Section G): ELLIPSE TECHNOLOGIES, INC.; 101 enterprise; suite 100; aliso viejo CA 92656
• Manufacturer Contact: john mcintyre ; 101 enterprise; suite 100; aliso viejo, CA 92656 ; 9498373600
• MDR Report Key: 5222097
• MDR Text Key: 31187051
• Report Number: 3006179046-2015-00038
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2015

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
• Device Expiration Date: 10/01/2014
• Device Model Number: RA002-5555SLR
• Device Lot Number: A120918-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2015
• Initial Date FDA Received: 11/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• 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): Hospitalization
• Patient Age: 13 YR
• Patient Weight: 36