MAUDE Adverse Event Report: HIGHRIDGE MEDICAL, LLC ADJUSTABLE TRANSVERSE CONNECTOR ASSEMBLIES 33-36 WIDE X 5.5 MM ROD; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	07.02030.001
Medical Device Problem Codes	Material Fragmentation (1261); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2026
Type of Reportable Event	Malfunction

• Brand Name: ADJUSTABLE TRANSVERSE CONNECTOR ASSEMBLIES 33-36 WIDE X 5.5 MM ROD
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW 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 ; 3035018506
• MDR Report Key: 25782130
• Report Number: 3012447612-2026-00178
• Device Sequence Number: 10752638
• Product Code: NKB
• UDI-Device Identifier: 03662663121569
• UDI-Public: (01)03662663121569(10)W732571
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150896
• 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): 07/09/2026

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: 07.02030.001
• Device Lot Number: W732571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2020
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian