MAUDE Adverse Event Report: CG MEDTECH CO., LTD. INNOVERSE SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW

Model Number	NPA8570PSQ
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A literature review indicates that, when a screw is directly coupled to the main rod, a smaller angulation between the screw head and screw body (shaft) may increase load concentration at the screw neck region (sohn et al.2018).Based on the record review and available information, no manufacturing anomaly was identified.The event is therefore presumed to have resulted from a combination of localized loading at the screw neck region associated with construct configuration and patient-specific clinical factors, including a higher likelihood of delayed union in an elderly female patient, leading to progressive accumulation of cyclic stress and subsequent fracture.As this is the first such case identified by the company, a design enhancement is under evaluation to reduce the likelihood of recurrence by reinforcing the iliac screw neck region.As no intrinsic quality issue with released product has been identified, the company will continue to monitor for similar events and assess trend information.
Event or Problem Description
Initial surgery was performed on (b)(6) 2025.During follow-up evaluation, an x-ray taken around (b)(6) 2026 identified a fracture at the neck region of the iliac screw implanted at the s2 level.A revision surgery was performed on(b)(6) 2026 to remove the fractured screw, and the implant was replaced.The fractured device was retrieved, and the manufacturing and inspection records for the associated lot were reviewed.The involved device was polyaxial std.Screw (quad) -8.5x70 mm (lot no.24k22130).Review of manufacturing and inspection records confirmed that compliant raw material within the required chemical composition and mechanical property specifications was used, and that the device geometry, dimensions, and visual appearance met applicable specifications.The device was designed to meet astm f1717 requirements considering clinically relevant loading conditions.

• 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: gyuhee lee ; 20 sandan-ro 76 beon-gil; uijeongbu-si, gyeonggi-do 11781 ; KS 11781
• MDR Report Key: 24516102
• Report Number: 3003200961-2026-00001
• Device Sequence Number: 8430721
• Product Code: NKB
• UDI-Device Identifier: 08800247364765
• UDI-Public: (01)08800247364765(11)241127(10)24K22130
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K233960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 03/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NPA8570PSQ
• Device Lot Number: 24K22130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian