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 Codes	Corroded (1131); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/10/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Information was received that the magnet appeared to be fractured internally and disassociated.Additionally, it was reported that fretting/corrosion is visible.No patient adverse event was reported.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: upon receipt of returned product visual inspection confirmed the reported failure as the rod was found to be broken.Due to the condition of the rod functional testing did not apply.The work order was reviewed and confirmed the device passed all inspections.The rod met manufacturing assembly specifications.The breakage is not related to a manufacturing processes or material issue/failure.The root cause was determined to be due to the patient¿s daily activities and unique anatomical structure which can influence the amount of stress applied to certain sections of the rod.Device records review: review of the device history record for the rod confirmed that it met all of the required quality inspections prior to release.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
Corrected data: h6 (investigation conclusions), h10 corrected device evaluation: the rod was observed to be fully distracted with score marks consistent with expected markings due to incremental distraction.There were no signs of corrosion and fretting were observed, therefore, the reported fretting/corrosion was unable to be confirmed.Based off of the visual inspection, the reported magnet fracture and disassociation failure was confirmed.The break in the rod caused the magnet to disassociate from the distraction rod.This can occur as the rod is not designed to withstand heavy bending loads that can be caused due to the patient¿s unique anatomical structure and daily activities.

• 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; ste 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr; ste 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr; ste 100; aliso viejo, CA 92656
• MDR Report Key: 12447032
• Report Number: 3006179046-2021-00457
• Device Sequence Number: 3651796
• Product Code: PGN
• UDI-Device Identifier: 00812258022679
• UDI-Public: 812258022679
• 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: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2022

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: MS1-5590R
• Device Lot Number: A14031319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 11/30/2021; 03/11/2022
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 12/02/2021; 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2014
• 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
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 98 KG