MAUDE Adverse Event Report: PARAGON 28, INC. TENOTAC SOFT TISSUE FIXATION SYSTEM

Model Number P42-122-0075

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

Devices are not expected to be returned for the manufacturer review/investigation.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.

Event Description

It was reported that the patient underwent a hammertoe correction surgical procedure that utilized paragon 28 tenotac soft tissue fixation system.The tenotac implant was removed post-operatively at 10 weeks because the patient felt the implant platarly.Upon the removal of the implant, the surgeon noted that the implant was loose and the implant removed easily.It was reported that the hammertoe correction was still in good shape.This is incident 2 of 2 for this report.

• Brand Name: TENOTAC SOFT TISSUE FIXATION SYSTEM
• Type of Device: TENOTAC
• Manufacturer (Section D): PARAGON 28, INC.; 14445 grasslands dr.; englewood CO 80112
• Manufacturer Contact: victoria akinboboye ; 14445 grasslands dr.; englewood, CO 80112 ; 7206431300
• MDR Report Key: 11281301
• MDR Text Key: 230438302
• Report Number: 3008650117-2021-00021
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: P42-122-0075
• Device Catalogue Number: P42-122-0075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2019
• 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): Required Intervention