MAUDE Adverse Event Report: PARAGON 28, INC PATIENT SPECIFIC TALUS SPACER; TITANIUM PATIENT SPECIFIC TALUS SPACER, SMALL

Model Number AOPSTSXXXXS-TI

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

3191 - an adverse event (e.G.Patient harm) appears to have occurred, but there does not appear to have been a problem with the device.The subject infection is device related with no alleged deficiency in a paragon 28 medical device.The healthcare provider noted the subject did not disclose a medical history of neuropathy prior to the patient specific total talus procedure.

Event Description

A patient specific talus spacer clinical study identified the subject had a wound infection approximately 4 weeks post device implantation.

• Brand Name: PATIENT SPECIFIC TALUS SPACER
• Type of Device: TITANIUM PATIENT SPECIFIC TALUS SPACER, SMALL
• Manufacturer (Section D): PARAGON 28, INC; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: jenny conger ; 14445 grasslands dr; englewood, CO 80112 ; 7203721212
• MDR Report Key: 19064969
• MDR Text Key: 339667886
• Report Number: 3008650117-2024-00022
• Device Sequence Number: 1
• Product Code: QNN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H200001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/08/2024

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: AOPSTSXXXXS-TI
• Device Catalogue Number: AOPSTSXXXXS-TI
• Device Lot Number: AOCIA1768
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 85 KG