MAUDE Adverse Event Report: PARAGON 28, INC UNKNOWN

Device Problem Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

Limited information is available for this event.Identifying information, including the part and lot number was not able to be obtained.The grappler screw is still implanted in the patient and is not expected to be returned for evaluation.If further information is identified which alters this event's conclusion, a supplemental report will be filed accordingly.

Event Description

During a post market clinical survey conducted on (b)(6) 2021, one of the paragon 28 grappler screws used in a deltoid reconstruction and fdl transfer conducted on (b)(6) 2020 was prominent and painful in the talus.The surgeon indicated on (b)(6) 2020 there would be a revision surgery to remove the grappler screw.As of (b)(6) 2021 no revision surgery had been conducted on this patient.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• Manufacturer (Section D): PARAGON 28, INC; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: jenny conger ; 14445 grasslands dr; englewood, CO 80112 ; 8557862828
• MDR Report Key: 12439581
• MDR Text Key: 271707516
• Report Number: 3008650117-2021-00105
• Device Sequence Number: 1
• Product Code: MBI
• 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: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• 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: 08/10/2021
• 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 Age: 22 YR
• Patient Weight: 114