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

Model Number MS1-5590R

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

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 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.

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 Description

This report has been updated to include investigation findings.

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
• Type of Device: GROWING ROD SYSTEM-MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise; suite 100; aliso viejo CA 92656
• MDR Report Key: 9279366
• MDR Text Key: 166127974
• Report Number: 3006179046-2019-00171
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00812258026325
• UDI-Public: 812258026325
• Combination Product (y/n): N
• PMA/PMN Number: K140613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR
• Patient Weight: 28