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 Codes	Mechanical Problem (1384); Failure to Advance (2524)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the device was not returned for evaluation.Root cause is unable to be determined at this time.
Event or Problem Description
Information was received that a revision procedure was performed on an unknown date.As per the reporter, the rod was not lengthening.No patient adverse event was reported.No additional information is available.
Additional Manufacturer Narrative
Device evaluation: upon return, visual inspection of the rod revealed it evidence of score marks consistent with expected markings due to incremental distraction.X-ray images of internal components for the rod reveal that the retaining ring that should be positioned inside the groove is out of the designed position.The rod was functionally tested and would not distract or retract using an external remote controller (erc) or a manual distractor, therefore, the reported failure was confirmed.Additionally, the rod was unable to be retracted or distracted with fast distractor during attempt of the stroke test.Due to the current condition of the rod (jammed) force testing can not be completed.The rod is likely jammed due to the retaining ring within the rod becoming misaligned preventing the magnet¿s rotation which possibly occurred due to excessive tensile loading applied to the retaining ring.The exact cause of the damage was unable to be confirmed.Device records review: review of work order revealed that the rod was visually inspected and functionally tested prior to release.The inspection data for the housing tube and the retaining ring also revealed that both parts passed all quality inspections and dimensional checks prior to being assembled and shipped.
Event or Problem Description
Additional information has been 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, suite 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: 11465462
• Report Number: 3006179046-2021-00193
• Device Sequence Number: 4189261
• Product Code: PGN
• UDI-Device Identifier: 00887517834027
• UDI-Public: 887517834027
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2023

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: 8100919AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/11/2021
• Supplement Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2018
• 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 Sex: Prefer Not To Disclose
• Patient Weight: 14 KG