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

Model Number	MS1-5590R
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation.No x-rays or ultrasound images provided to confirm the alleged event.No root cause can be confirmed at this time.
Event or Problem Description
Information was received that a patient underwent a posterior spinal instrumentation implant approximately three years ago.The implants were stryker screws but magec rods along with bone grafting posterior arthrodesis t2, t3, t4 and also l1 and l2.After two adjustments of the rods, the patient had the rods removed due to the failure of the rods lengthening transcutaneously.This patient underwent removal of the rods last month and had replacement with solera screws, connectors, and rods.No complications and patient was discharged from the hospital without concerns.
Additional Manufacturer Narrative
Investigation findings: product was returned and visual inspection was performed, customers alleged event was confirmed.Based on the investigation findings bending forces applied to the rod from patient¿s anatomy/activity may have caused the distraction rod to wedge into the housing tube and caused wear and tear, which would cause the rod to be jammed.Review of the device history record revealed no discrepancies related to this complaint.The rod was manufactured in accordance with the specified requirements and met all of the required quality inspections.
Event or Problem Description
This report has been updated to include investigation findings.
Additional Manufacturer Narrative
Please provide the disposition of the device, including the implant and associated instruments (e.G., controller).In your disposition, please include information on your efforts to acquire or have the device returned for investigation.For reusable devices (e.G., controller instrument), indicate whether the device is still in use.The reporter was contacted on october 15, 2019 via phone to get additional information and have the device returned for evaluation.To date, the rods have not been returned for evaluation to the manufacturer, however; return postage has been provided.Once the rods have been returned, they will be evaluated and the additional information requested from report number 2633020000-2019-8013 will be provided.

• 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: 9279366
• Report Number: 3006179046-2019-00171
• Device Sequence Number: 2145720
• Product Code: PGN
• UDI-Device Identifier: 00812258026325
• UDI-Public: 812258026325
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K140613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2020

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: MS1-5590R
• Device Catalogue Number: PA0519
• Device Lot Number: A150513-07-00-03U
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 12/04/2019; 03/25/2020
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 12/04/2019; 09/22/2020
• 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
• Patient Age: 10 YR
• Patient Weight: 28