MAUDE Adverse Event Report: HIGHRIDGE MEDICAL, LLC PERCUTANEOUS PRE-BENT ROD 40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	3510-040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2026
Type of Reportable Event	Malfunction

• Brand Name: PERCUTANEOUS PRE-BENT ROD 40MM
• 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: 25785390
• Report Number: 3012447612-2026-00180
• Device Sequence Number: 10722023
• Product Code: NKB
• UDI-Device Identifier: 00889024335837
• UDI-Public: (01)00889024335837(10)CT125895
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K132884
• 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: 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: Lay User/Patient
• Device Catalogue Number: 3510-040
• Device Lot Number: CT125895
• 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: 03/27/2020
• 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