MAUDE Adverse Event Report: Highridge Medical, LLC PE-INLAY 8.5MM; Prosthesis, Intervertebral Disc

Catalog Number	SW965-HM
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction

• Brand Name: PE-INLAY 8.5MM
• Common Device Name: Prosthesis, Intervertebral Disc
• 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: 50810257
• Report Number: 3012447612-2026-00245
• Device Sequence Number: 8900721
• Product Code: MJO
• UDI-Device Identifier: 03662663082112
• UDI-Public: (01)03662663082112
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P120024
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: SW965-HM
• 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: 09/17/2026
• 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
• Patient Sex: Unknown