MAUDE Adverse Event Report: CG MedTech Co., Ltd. INNOVERSE SPINAL SYSTEM; POLYAXIAL RED. SCREW (QUAD), 6.5 x 45mm

Model Number	NPA6545PRQ
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a surgical procedure, while adjusting the position of the rod, separation of the screw from the tulip (head) of a pedicle screw occurred.No patient harm resulted from this event.The separated screw was removed and replaced with another screw, and the surgery was completed without further incident.A review of the production and inspection records for the separated polyaxial red.Screw (quad), 6.5 x 45mm (lot no.24a15008), confirmed that raw materials meeting the required chemical composition and mechanical property specifications were used, and that the product's dimensions and appearance were manufactured in conformance with the design specifications.No other anomalies were identified in the production or inspection records.In this pedicle screw design, the inner cap inside the tulip engages the head of the screw to prevent it from disengaging.During rod adjustment, if the inner cap becomes pinched at the top of the tulip, a gap can form that allows the collet portion of the inner cap to open wider than normal.This can allow the screw head to pass through the widened collet, resulting in separation of the screw from the tulip.However, once the rod and set screw are properly engaged with the pedicle screw under normal surgical conditions, the inner cap is compressed such that the screw cannot separate from the tulip.Therefore, once the implant is in its final, fully assembled configuration, the likelihood of a significant impact on safety or patient harm is considered low.Although the existing product was determined to remain safe for continued use based on this evaluation, the manufacturer voluntarily implemented a design change to minimize the recurrence of this phenomenon and address user concern.This event occurred on (b)(6)2025, but was not initially determined to be a reportable mdr upon initial awareness.This report is being submitted retrospectively as a correction to address the finding identified during the fda inspection.

• Brand Name: INNOVERSE SPINAL SYSTEM
• Common Device Name: POLYAXIAL RED. SCREW (QUAD), 6.5 x 45mm
• Manufacturer (Section D): CG MedTech Co., Ltd.; 20 sandan-ro 76 beon-gil; uijeongbu-si, gyeonggi-do 11781 ; KS 11781
• Manufacturer (Section G): CG MedTech Co., Ltd.; 20 sandan-ro 76 beon-gil; uijeongbu-si, gyeonggi-do 11781 ; KS 11781
• Manufacturer Contact: hyejin hong ; 20 sandan-ro 76 beon-gil; uijeongbu-si, gyeonggi-do 11781 ; KS 11781
• MDR Report Key: 50927670
• Report Number: 3003200961-2026-00006
• Device Sequence Number: 15827335
• Product Code: NKB
• UDI-Device Identifier: 08800037596710
• UDI-Public: (01)08800037596710(11)240229(10)24A15008
• 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: Non-Healthcare Professional
• Remedial Action: Replace,Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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
• Operator of Device: Health Professional
• Device Model Number: NPA6545PRQ
• Device Lot Number: 24A15008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• 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
• Patient Sex: Unknown