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

Model Number MC2-6090S, MC2-6090R

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

The devices were not returned for evaluation therefore an analysis was not performed.X-ray images were provided by the distributor however could not confirm the rods had a broken locking pin due to the quality of the images.No x-ray image provided of tissue discoloration therefore could not confirm.A review of the lot history record for the devices revealed that the devices met all of the required quality inspections and that the products were released within specifications.

Event Description

It was reported that allegedly the patient's x-ray revealed the magec standard rod was damaged after three (3) years of implantation.The physician removed the magec rods and fused the patient due having enough trunk height, and old enough.It was observed during removal there was tissue discoloration, and both magec rods were damaged and pistoning.

• 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: karen jaffe ; 101 enterprise, suite 100; aliso viejo, CA 92656 ; 9495446507
• MDR Report Key: 8376479
• MDR Text Key: 139197742
• Report Number: 3006179046-2019-00027
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MC2-6090S, MC2-6090R
• Device Lot Number: A150519-12, A150519-14
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 11 YR
• Patient Weight: 76