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

Model Number MS1-5590R, MC2-5590S

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688)

Event Date 09/03/2018

Event Type  malfunction  

Event Description

It was reported that allegedly it was observed on x-ray that one of the magec rods was damaged; after over two (2) years of implantation.The patient had reported to been physically assaulted, and landed on their back.The physician explanted the rods due to final fusion.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: GROWING ROD SYSTEM-MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise, suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise, suite 100; aliso viejo CA 92656
• Manufacturer Contact: claudia alvarez ; 101 enterprise, suite 100; aliso viejo, CA 92656 ; 9496528012
• MDR Report Key: 8422987
• MDR Text Key: 138966518
• Report Number: 3006179046-2019-00105
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K140613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MS1-5590R, MC2-5590S
• Device Lot Number: A140422-07-02, A150608-13-00-0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2018
• 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 Age: 13 YR