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

Model Number MS1-5570S

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 12/21/2017

Event Type  Injury  

Event Description

It was reported that a patient's magec rod was removed after over three (3) years of implantation; rod did not appear to be functioning.The physician revised the rod with a new magec rod without incident.

• 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: carol bleakley ; 101 enterprise; aliso viejo, CA 92656
• MDR Report Key: 7236515
• MDR Text Key: 98839470
• Report Number: 3006179046-2018-00009
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2018

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 Model Number: MS1-5570S
• Device Catalogue Number: PA0563
• Device Lot Number: A141118-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2018
• Initial Date FDA Received: 02/02/2018
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 8 YR
• Patient Weight: 25