MAUDE Adverse Event Report: PARAGON 28, INC. BABY GORILLA/GORILLA PLATING SYSTEM; DEPTH GAUGE PLATE SCREW, 70MM SCREW

Model Number P99-150-0014

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

Identifying information, such as the lot number of the device was not reported to paragon 28.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 during a surgical procedure on (b)(6) 2020, a paragon 28 70mm screw depth gauge broke.

• Brand Name: BABY GORILLA/GORILLA PLATING SYSTEM
• Type of Device: DEPTH GAUGE PLATE SCREW, 70MM SCREW
• Manufacturer (Section D): PARAGON 28, INC.; 14445 grasslands dr.; englewood CO 80112
• Manufacturer Contact: victoria akinboboye ; 14445 grasslands dr.; englewood, CO 80112
• MDR Report Key: 11458403
• MDR Text Key: 242529526
• Report Number: 3008650117-2021-00049
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K190365
• 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: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P99-150-0014
• Device Catalogue Number: P99-150-0014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 66 YR