MAUDE Adverse Event Report: PARAGON 28, INC TENOTAC SOFT TISSUE FIXATION SYSTEM; Screw, fixation, bone

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

Patient Problem Failure of Implant (1924)

Event Date 01/30/2023

Event Type  malfunction  

Manufacturer Narrative

4247 - a limited investigation was able to be performed with no results able to be obtained.

Event Description

The female and male implants are backing out/loosening during patient use with no impact to the patient.

• Brand Name: TENOTAC SOFT TISSUE FIXATION SYSTEM
• Type of Device: Screw, fixation, bone
• 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: 16454674
• MDR Text Key: 310371452
• Report Number: 3008650117-2023-00047
• 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
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female