MAUDE Adverse Event Report: PARAGON 28 LATERAL TTC PLT LG LT; PLATE, FIXATION, BONE

Catalog Number	P53-402-L102
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in united kingdom.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported the plates removed from the patient on a lateral ttc plate implanted on the patient for diabetic foot reconstruction 6 weeks post-operation due to fatigue at the screw wall on the posterior section of the plate.This continued to progress until the plate snapped on the interface between the tibia section of the plate and the talus interface.Attempts have been made and all available information has been provided.

• Brand Name: LATERAL TTC PLT LG LT
• Common Device Name: PLATE, 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 ; 5745260384
• MDR Report Key: 24860983
• Report Number: 3008650117-2026-00179
• Device Sequence Number: 10549371
• Product Code: HRS
• UDI-Device Identifier: 00889795053169
• UDI-Public: (01)00889795053169(10)RZ209424
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K190365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 04/13/2026

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: Lay User/Patient
• Device Catalogue Number: P53-402-L102
• Device Lot Number: RZ209424
• Was Device Available for Evaluation?: No
• 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: 03/30/2026
• Initial Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 148 KG