MAUDE Adverse Event Report: Highridge Medical, LLC CORD 300MM; Vertebral Body Tethering System

Catalog Number	204H0300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery had been performed 18 months post-op to address a tether cord that had fractured at t9-10.Removal of the cord from t4-t12 was completed, the tether was locked at t5 and screws were replaced at t6, t7, and t11.The cord was then re-tensioned t5-t12.
Additional Manufacturer Narrative
This event was initially reported on voluntary medwatch mw518971.Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

• Brand Name: CORD 300MM
• Common Device Name: Vertebral Body Tethering System
• 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: 50148144
• Report Number: 3012447612-2026-00203
• Device Sequence Number: 9103151
• Product Code: QHP
• UDI-Device Identifier: 00880304865068
• UDI-Public: (01)00880304865068(10)3114468
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: H190005
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 204H0300
• Device Lot Number: 3114468
• 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: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown Tether Screws (211Hxxx) at T6, T7, and T11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 127 LB
• Patient Race: White