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

Device Problem Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Identifying information, such as the part number and lot number of the device was not reported to paragon 28.Case information including surgery date(s), or related patient information was not provided by the initial reporter.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 a paragon 28 tenotac soft tissue fixation system.Upon the follow-up appointment, it was discovered that the tenotac implant had backed out post-operatively and the patient's toe was back up.It was reported that the surgeon planned on re-tightening the tenotac however, a revision surgery was not reported.

• 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: 10973543
• MDR Text Key: 221263038
• Report Number: 3008650117-2020-00234
• 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: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2019
• 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