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

Model Number	MC2-5070S
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received and is pending evaluation.The root cause is unable to be determined at this time.A supplemental report will be submitted following the evaluation.
Event or Problem Description
Information was received that the rod was not lengthening.No patient harm was reported.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Additional data: h3, h6, h10 corrected data: d4 (lot number),g4, h6 (impact code & clinical code) device evaluation: visual inspection of the returned rod showed score marks on the distraction rod.The rod was unable to be distracted with the manual distractor and external remote controller (erc).Additionally, the rod was unable to be retracted with fast distractor.X-ray images of the internal components revealed a broken cylinder magnet.The reported failure was therefore confirmed as the rod was not able to be distracted or retracted.The exact root cause for the cylinder magnet fracture is unknown.Device records review: 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 before shipment.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
Additional device evaluation: measurements of the score marks confirmed the distraction rod was extended approximately 9mm from its initial position.The inspection data for the cylinder magnet (lot#171121-11) has been reviewed and confirmed the part met design specifications per the engineering drawings.Magnet fracture is a known inherent risk of the device.The exact root cause of the broken cylinder magnet is unable to be determined, however, the following possible root causes have been identified: the titanium casing was insufficient to protect magnet from loading; improper assembly of the magnet module resulting in unintended loading of the magnet; failure of the epoxy bond resulting in unintended loading of the magnet.

• 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, suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr, suite 100; aliso viejo, CA 92656
• MDR Report Key: 12161227
• Report Number: 3006179046-2021-00407
• Device Sequence Number: 4199189
• Product Code: PGN
• UDI-Device Identifier: 00887517834027
• UDI-Public: 887517834027
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K201543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2022

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: MC2-5070S
• Device Lot Number: 7121602AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• 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: 06/23/2021
• Supplement Date Received by Manufacturer: 05/19/2022; 08/17/2022
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 06/17/2022; 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2017
• 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
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Sex: Female
• Patient Weight: 37 KG