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

Model Number	MS1-4570S
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for investigation nor were x-rays or ultrasound images provided to confirm the alleged event.It is unknown if patient complied with post-operative physical restrictions.Labeling review: warnings: ".Warning: metallic implants can loosen, fracture, corrode, migrate, or cause pain.".
Event or Problem Description
It was reported patient underwent a revision procedure.As per reporter, it is unknown if the product reached terminal distraction length.
Additional Manufacturer Narrative
The rods were received for functional and visual testing and the reported event was confirmed.The root cause of the reported event may be related to bending force applied during the distraction sessions and/or patient's daily activities.

• 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: 8918902
• Report Number: 3006179046-2019-00141
• Device Sequence Number: 13581636
• Product Code: PGN
• UDI-Device Identifier: 00812258026332
• UDI-Public: 812258026332
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K140613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MS1-4570S
• Device Catalogue Number: PA0561
• Device Lot Number: A150818-08, A160111-16
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 11/19/2019
• 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: Hospitalization
• Patient Age: 8 YR