MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED MAGEC GENERATION 2 SPINAL BRACING AND DISTRACTION SYSTEM; GROWING ROD SYSTEM - MAGNETIC ACTUATION

Model Number	MS2-6090S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Drug Resistant Bacterial Infection (4553)
Date of Event	10/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A revision procedure was performed after several incision and drainage (i&d) procedures to address an abscess with wound closure.This was required due to an infection following device implantation.
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.

• Brand Name: MAGEC GENERATION 2 SPINAL BRACING AND DISTRACTION SYSTEM
• Common Device Name: GROWING ROD SYSTEM - MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 2560 general armistead avenue; audubon PA 19104
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: whitney ginter ; 2560 general armistead avenue; audubon, PA 19403 ; 8582005905
• MDR Report Key: 20835908
• Report Number: 3006179046-2024-00186
• Device Sequence Number: 12918603
• Product Code: PGN
• UDI-Device Identifier: 00812258022938
• UDI-Public: 812258022938
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K233593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2024

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: MS2-6090S
• Device Lot Number: 9121016
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 7 YR
• Patient Sex: Male