MAUDE Adverse Event Report: PARAGON 28, INC TENOTAC SOFT TISSUE FIXATION SYSTEM; TENOTAC STERILE KIT SYSTEM, Ø8MM X 2.2MM X 7.5MM

Model Number P42-222-0075-SK

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 01/27/2023

Event Type  Injury  

Event Description

The male and female implants backed out of each other during patient use 7 weeks post implantation.

• Brand Name: TENOTAC SOFT TISSUE FIXATION SYSTEM
• Type of Device: TENOTAC STERILE KIT SYSTEM, Ø8MM X 2.2MM X 7.5MM
• 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: 16403363
• MDR Text Key: 309863551
• Report Number: 3008650117-2023-00040
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: P42-222-0075-SK
• Device Catalogue Number: P42-222-0075-SK
• Device Lot Number: 260A05922A01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2022
• 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): Required Intervention; Other
• Patient Age: 55 YR
• Patient Sex: Male