MAUDE Adverse Event Report: Highridge Medical, LLC 4.0X26MM PA SCREW VIRAGE GOLD; Appliance, Fixation, Spinal Interlaminal

Catalog Number	07.01702.062
Medical Device Problem Codes	Material Deformation (2976); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during posterior fixation from c3 to t3, the screws were implanted and the rod was seated.While attempting to provisionally tighten the set screw, an abnormal noise was heard from the left c7 screw and the set screw could not be properly seated.The screw was removed and inspected, revealing that a portion of the internal threading of the tulip head was deformed.The screw was therefore determined to be unusable and was discarded.The affected screw was replaced with a new one, and the procedure was completed without any further issues.There was no patient impact.
Additional Manufacturer Narrative
A review of the dhr was conducted and found no indications of manufacturing issues.This event likely cannot be attributed to manufacturing or design related issues, the device was not returned and no photos were provided, so an evaluation is unable to be performed.The complaint is unrefuted for virage screw for the failure of stripped threads.The failure could possibly be attributed to excessive forces being applied beyond intended use.This device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

• Brand Name: 4.0X26MM PA SCREW VIRAGE GOLD
• Common Device Name: Appliance, Fixation, Spinal Interlaminal
• Manufacturer (Section D): Highridge Medical, LLC; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): Highridge Medical, LLC; 10225 westmoor dr.; westminster CO 80021
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; +1(303)501-8506
• MDR Report Key: 50483776
• Report Number: 3012447612-2026-00231
• Device Sequence Number: 18669990
• Product Code: KWP
• UDI-Device Identifier: 00889024327559
• UDI-Public: (01)00889024327559(10)AAT
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133556
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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 Catalogue Number: 07.01702.062
• Device Lot Number: AAT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Standard Closure Top (07.01728.001), lot unknown.
• Patient Sex: Unknown