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

Model Number RA002-5555SL

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 07/31/2015

Event Type  Injury  

Manufacturer Narrative

Pt specifics with regard to age and weight were not provided; the rod was removed and the pt was implanted with a new magec rod, without incident.No negative outcomes were reported.A dhr review was performed and no discrepancies were found related to the mfg process.The device met all the required quality inspections and was released within specs.

Event Description

A distributor reported that a pt's magec was removed; the rod allegedly broke after over two (2) years of implantation.

Manufacturer Narrative

Information was received that the initial report was not submitted.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: GROWING ROD SYSTEM- MAGNETIC ACTUATION
• Manufacturer (Section D): ELLIPSE TECHNOLOGIES, INC.; 13900 alton pkwy; ste 123; irvine CA 92618
• Manufacturer (Section G): ELLIPSE TECHNOLOGIES, INC.; 13900 alton pkwy; ste 123; irvine CA 92618
• Manufacturer Contact: john mcintyre ; 13900 alton pkwy; ste 123; irvine, CA 92618 ; 9498373600
• MDR Report Key: 5154882
• MDR Text Key: 317546638
• Report Number: 3006179046-2015-00029
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2020

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: Other
• Device Expiration Date: 08/01/2014
• Device Model Number: RA002-5555SL
• Device Catalogue Number: PA0239
• Device Lot Number: A120625-07
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/31/2015
• Initial Date FDA Received: 10/15/2015
• Supplement Dates Manufacturer Received: 07/31/2015; 07/31/2015
• Supplement Dates FDA Received: 10/15/2015; 11/16/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female