MAUDE Adverse Event Report: CG MedTech Co., Ltd. INNOVERSE SPINAL SYSTEM; Thoracolumbosacral Pedicle Screw,

Model Number	NPA2030
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6)2026, during surgery using the innoverse spinal system at (b)(6), an issue occurred during the cross link set screw fastening process.According to the customer report, the hex portion of the cross link set screw became worn during fastening, and the cross link was reported to have fractured.The same issue occurred during a second attempt, and the surgery was completed without using the cross link.No patient symptoms, additional treatment, reoperation, prolonged hospitalization, health impact, or clinical impact related to this event were reported.
Additional Manufacturer Narrative
The returned cross link was inspected, and wear and indentation marks were observed inside the set screw hex portion.The damage was concentrated in the upper area of the hex portion.No abnormality was identified in the torque function of the returned torque limiting handle, and the driver was confirmed to be normal in both appearance and function.Based on the investigation, the driver hex portion and the set screw hex portion may not have been fully engaged to a sufficient depth during fastening due to surrounding muscle and soft tissue, the surgical approach angle, or other procedural conditions.In this condition, the fastening force may have been concentrated in a specific area rather than being evenly distributed across the set screw hex portion, which could result in wear, indentation, or deformation.Therefore, this event is considered to have been caused by insufficient engagement depth and alignment between the driver and the set screw hex portion during the cross link set screw fastening process, rather than a functional abnormality of the product itself.As an improvement action, a cross link product with a vertically oriented fastening direction will be provided to improve alignment between the driver and the set screw hex portion and to reduce the possibility of localized load concentration during fastening.The effectiveness of the action will be verified by monitoring for recurrence of the same issue.

• Brand Name: INNOVERSE SPINAL SYSTEM
• Common Device Name: Thoracolumbosacral Pedicle Screw,
• Manufacturer (Section D): CG MedTech Co., Ltd.; 20 sandan-ro 76 beon-gil; uijeongbu-si, gyeonggi-do 11781 ; KS 11781
• Manufacturer Contact: choi ye-seul ; 20 sandan-ro 76 beon-gil; uijeongbu-si, gyeonggi-do 11781 ; KS 11781
• MDR Report Key: 50364822
• Report Number: 3003200961-2026-00004
• Device Sequence Number: 21497996
• Product Code: NKB
• UDI-Device Identifier: 08800247361887
• UDI-Public: (01)08800247361887(11)251001(10)25I25036
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K233960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 08/21/2026

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
• Device Model Number: NPA2030
• Device Lot Number: 25I25036
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2025
• 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: Female