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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Fever (1858)
Date of Event	10/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.Root cause is unable to be determined at this time.Device has not been returned.
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2020.As per the reporter the patient was febrile post-op and was found to have purulence thoracic wound dehiscence found at the expansion end of the rod.The patient was treated with antibiotics and had a culture and immunodeficiency work up.
Additional Manufacturer Narrative
Evaluation summary: no device problems were identified.The returned rod was observed to be partially distracted.No contamination or scratches were visible.The rod was functionally tested and met specifications.During the functional testing no fluid/material was extruded out of the actuator.Review of the device history records revealed no discrepancies related to this complaint; the rods were manufactured in accordance with the specified requirements and met all release criteria.

• 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 dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 10872388
• Report Number: 3006179046-2020-00473
• Device Sequence Number: 16867668
• Product Code: HGB
• UDI-Device Identifier: 00812258026332
• UDI-Public: 812258026332
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

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
• Operator of Device: Health Professional
• Device Model Number: MS1-4570S
• Device Lot Number: 0071501-AAC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 03/17/2021
• 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: 6 YR
• Patient Weight: 15