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

Model Number	MC2-5570S
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/12/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: GROWING ROD SYSTEM-MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise; suite 100; aliso viejo CA 92656
• MDR Report Key: 9345414
• Report Number: 3006179046-2019-00176
• Device Sequence Number: 1927882
• Product Code: PGN
• UDI-Device Identifier: 00812258022648
• UDI-Public: 812258022648
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K140613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: MC2-5570S
• Device Catalogue Number: PA0684-008
• Device Lot Number: 150618
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention