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

Model Number	MS1-5590S
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/31/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2019.As per reporter, after multiple attempts to lengthen in clinic, the rod showed no sign of distraction.
Additional Manufacturer Narrative
Investigation results: the device was received for visual and functional testing.Visual testing revealed score marks on the rod due to incremental distractions.Functional testing revealed the rod was unable to distract with manual distractor and the electronic remote controller (erc).The rod was sectioned and debris build up was found, which may have caused the reduced functionality.Sectioning of the rod determined that it could not be separated from the housing without use of high force.Bending forces applied to the rod from patient anatomy/activity may have caused the distraction rod to wedge into the housing tube, which would cause the rod to be jam.
Event or Problem Description
This report has been updated to include investigation findings.

• 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: 9370964
• Report Number: 3006179046-2019-00177
• Device Sequence Number: 16693649
• Product Code: PGN
• UDI-Device Identifier: 00812258026325
• UDI-Public: 812258026325
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 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: MS1-5590S
• Device Catalogue Number: PA0518
• Device Lot Number: A140213-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 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: 11 YR
• Patient Weight: 31