MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. SI-LOK; TRANS-FACET-SCREW INTERNAL SPINAL FIXATION SYSTEM, STERILE

Model Number	139.503S
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No part, images, or lot number were returned.Dhr records could not be evaluated.The eef indicated there were no adverse events to the patient.A risk evaluation was conducted (above), and it was found that the observed risk level (low) is within the expected risk level (medium).The rep confirmed the surgeon felt there was no device problem and that it was best to not reoperate.The mir worksheet has been completed, with no trend observed, and is attached.Since the observed risk is within the expected risk level, no further actions will be taken at this time.No further evaluation was possible.This evaluation will be reopened if more information becomes available.Based on the evaluation and available information.
Event or Problem Description
It was reported that there has been an inquiry from a surgeon who implanted silok in 2024 about removal.The patient believes that the implant is causing pain and wants the implant removed.The surgeon believes the joint is fused and that removal may not be the best course of action.

• Brand Name: SI-LOK
• Common Device Name: TRANS-FACET-SCREW INTERNAL SPINAL FIXATION SYSTEM, STERILE
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 25033628
• Report Number: 3004142400-2026-00086
• Device Sequence Number: 8919641
• Product Code: OUR
• UDI-Device Identifier: 00889095184884
• UDI-Public: 00889095184884
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K112028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

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: 139.503S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Male
• Patient Race: White