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

Model Number	MC2-5090S
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Failure of Implant (1924); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that the rod did not fully achieve the desired distraction increments during lengthening sessions.The device was removed for final fusion.Additionally, it was reported that there was organic matter buildup around the rod and tissue discoloration.No patient adverse reaction or impact was reported.
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.
Additional Manufacturer Narrative
Upon return, visual inspection of the rod revealed that it was partially distracted with score marks consistent with expected markings due to incremental distraction.Inspection also revealed there was no visible "cellulose buildup" to confirm the reported issue.X-ray images of the internal components showed no damage and revealed the rod was partly distracted.Functional testing revealed the rod was unable to be distracted or retracted with the manual distractor or electronic remote controller (erc) as the rod was found to be jammed.To complete a thorough inspection, the rod was sectioned and debris buildup was found around the distraction rod.It was also determined that the rod could not be separated from the housing tube without use of high force.This indicates bending forces were applied to the distraction rod causing it to contact the housing, possibly from patient activity.Review of the device history records 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
No additional information was 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 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 ; 8583448112
• MDR Report Key: 13182236
• Report Number: 3006179046-2022-00106
• Device Sequence Number: 2007817
• Product Code: PGN
• UDI-Device Identifier: 00887517834041
• UDI-Public: 887517834041
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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
• Report Date (Section B): 02/21/2022

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: MC2-5090S
• Device Lot Number: 8071101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• 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: 12/13/2021
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2018
• 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: 12 YR
• Patient Sex: Female
• Patient Weight: 32 KG