MAUDE Adverse Event Report: PARAGON 28, INC. MONSTER SCREW SYSTEM; SCREW, FIXATION, BONE

Model Number P20-535-030S

Device Problems Material Fragmentation (1261); Peeled/Delaminated (1454)

Patient Problem Insufficient Information (4580)

Event Date 04/29/2016

Event Type  malfunction  

Manufacturer Narrative

The review of the device history records of the screw used during the surgery indicate that the device was manufactured according to specification and no deviations were noted for the released product.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 metatarso-phalangeal (mtp) fusion surgical procedure that utilized paragon 28 monster screw system on (b)(6) 2016.Upon insertion of the first screw, a 3.5mm mini-monster screw, the distal threads delaminated from the body of the screw.Both the screw and the loose fragments were removed from the patient.A replacement screw was used to complete the surgery.It was reported that standard technique was followed.

• Brand Name: MONSTER SCREW SYSTEM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): PARAGON 28, INC.; 14445 grasslands dr.; englewood CO 80112
• Manufacturer Contact: mackenzie belden ; 14445 grasslands dr.; englewood, CO 80112 ; 7206431300
• MDR Report Key: 10979461
• MDR Text Key: 221278053
• Report Number: 3008650117-2020-00144
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190568
• 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: 12/09/2020

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
• Device Model Number: P20-535-030S
• Device Catalogue Number: P20-535-030S
• Device Lot Number: PA5348/10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 36 YR