MAUDE Adverse Event Report: CG MEDTECH CO., LTD. PERFIX ILIAC SCREW SYSTEM; ORTHOSIS, SPONDYLOLISTHESIS SPIN

Model Number	SL9510
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fistula (1862); Unspecified Infection (1930); Implant Pain (4561)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fracture location is considered to be at the start of the screw's thread transition region.Based on our review, the fracture location is assessed to be at the transition area where the incomplete thread begins.This transition area can be more susceptible to localized stress concentration due to the change in the core diameter geometry.From the x-ray images, the sacropelvic fixation is presumed to have been performed using the s2-alar-iliac (s2ai) technique.With the s2ai configuration, the transition area may overlap with the si joint boundary region, which could increase the influence of load transfer and potential micro-motion.In addition, considering that the fracture was identified approximately 10 months post-operatively, there is a higher possibility of a delayed union associated with osteoporosis.In such circumstances, physiological load sharing may not be adequately transferred through the surrounding bone tissue.Consistent with this, the literature reports that osteoporosis is associated with an approximately 3.7-fold increased risk of implant failure (choi et al., 2020).The combined effect of these factors may have contributed to sustained fatigue loading concentration at the transition area over time, ultimately progressing to fracture.
Event or Problem Description
In (b)(6) 2024, approximately 10 months after the initial surgery performed on (b)(6) 2023, the patient presented with pain and discomfort.X-ray imaging confirmed a fracture of the iliac screw body, and revision surgery was performed on (b)(6) 2024 to remove the fractured screw.The patient's symptoms have improved following the revision procedure.According to the patient's statement, persistent pain had been present since screw implantation, and there was prolonged hospitalization due to a fistula and infection.The involved device was iliac screw - 9.5x100 mm (lot no.14k294).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.

• Brand Name: PERFIX ILIAC SCREW SYSTEM
• Common Device Name: ORTHOSIS, SPONDYLOLISTHESIS SPIN
• 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: 24516065
• Report Number: 3003200961-2026-00002
• Device Sequence Number: 9691853
• Product Code: MNH
• UDI-Device Identifier: 08800015931816
• UDI-Public: (01)08800015931816(11)141224(10)14K294
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K132218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• 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: SL9510
• Device Lot Number: 14K294
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/24/2014
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 65 KG