MAUDE Adverse Event Report: Paragon 28 SCW DRV ATTCH CAN AO HX-6; Screw, Fixation, Bone

Catalog Number	P99-190-TX06
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction

• Brand Name: SCW DRV ATTCH CAN AO HX-6
• Common Device Name: Screw, Fixation, Bone
• Manufacturer (Section D): Paragon 28; 14445 grasslands dr.; englewood CO 80112
• Manufacturer (Section G): Paragon 28; 14445 grasslands dr.; englewood CO 80112
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50736949
• Report Number: 3008650117-2026-00502
• Device Sequence Number: 18799981
• Product Code: HWC
• UDI-Device Identifier: 00889795052070
• UDI-Public: (01)00889795052070(10)TC2003060
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: Exempt
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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: P99-190-TX06
• Device Lot Number: TC2003060
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/21/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown