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

Model Number MC2-5570S

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 08/12/2019

Event Type  Injury  

Manufacturer Narrative

The product was returned to the manufacturer and the device evaluation findings are not yet available.Radiographs provided confirmed the alleged event.No root cause can be confirmed at this time.

Event Description

Information was received that a revision procedure was performed on (b)(6) 2019.As per reporter, the rods were removed because they were no longer lengthening with the external remote controller erc.The rods were implanted for approximately 1.5 years.

Manufacturer Narrative

The rods were returned for visual and functional testing and the reported issue was confirmed.The root cause can be attributed to bending forces applied on the rod during distraction sessions coupled with the patient's daily activities and unique anatomical structure.

• 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
• MDR Report Key: 9345414
• MDR Text Key: 167125195
• Report Number: 3006179046-2019-00176
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00812258022648
• UDI-Public: 812258022648
• Combination Product (y/n): N
• PMA/PMN Number: K140613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC2-5570S
• Device Catalogue Number: PA0684-008
• Device Lot Number: 150618
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention