MAUDE Adverse Event Report: HIGHRIDGE MEDICAL, LLC NTINOL GUIDEWIRE 1.6MM X 510MM BLUNT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	14-500360
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: the remainder of the udi number is unknown because the lot number is not available.Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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.
Event or Problem Description
It was reported that when trying to remove a k-wire from the patient after inserting vital mis screws intra-operatively, the tip of the wire fractured off.The tip remains embedded in the vertebral body but the patient is asymptomatic and there was no other patient or procedural impact.

• Brand Name: NTINOL GUIDEWIRE 1.6MM X 510MM BLUNT
• 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: 25786082
• Report Number: 3012447612-2026-00182
• Device Sequence Number: 18821787
• Product Code: NKB
• UDI-Device Identifier: 03662663133630
• UDI-Public: (01)03662663133630
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K121130
• 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: Health Professional,Distributor
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 14-500360
• 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
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 19 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic