MAUDE Adverse Event Report: PARAGON 28, INC TENOTAC SOFT TISSUE FIXATION SYSTEM; TENOTAC® 2.0 STERILE KIT - STANDARD

Model Number P42-222-0075-SK

Device Problem Separation Problem (4043)

Patient Problem Failure of Implant (1924)

Event Date 06/16/2022

Event Type  Injury  

Event Description

The female implant lost tension and became disconnected from the male implant during patient use.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

B2 - new info.D5 - corrected information.D6b - new info.D9 - new info.H1 - updated info.H3 - new (additional) info (additional attachment).H6 - health effect - impact code (updated/corrected info): 4629.H6 - type of investigation (updated/corrected info): 4112, 4109, 4111, 4331.

• Brand Name: TENOTAC SOFT TISSUE FIXATION SYSTEM
• Type of Device: TENOTAC® 2.0 STERILE KIT - STANDARD
• 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: 14991171
• MDR Text Key: 296579539
• Report Number: 3008650117-2022-00072
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• 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 Lot Number: 260A05922A01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/16/2022
• 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