MAUDE Adverse Event Report: PARAGON 28, INC. BABY GORILLA/GORILLA PLATING SYSTEM; CURETTE

Model Number P99-150-0091

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 08/19/2019

Event Type  malfunction  

Manufacturer Narrative

Case information including facility, surgeon's information or related patient information was not provided by the initial reporter.The device history record was reviewed and met all material specifications with no deviation identified.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 surgical procedure that utilized paragon 28 baby gorilla/gorilla plating system.The mini curette, large, 20° was reported to have snapped in half intra-operatively.No further information was reported by the initiator.

• Brand Name: BABY GORILLA/GORILLA PLATING SYSTEM
• Type of Device: CURETTE
• 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: 11159453
• MDR Text Key: 232850090
• Report Number: 3008650117-2021-00005
• Device Sequence Number: 1
• Product Code: HTF
• Combination Product (y/n): N
• PMA/PMN Number: K190365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P99-150-0091
• Device Catalogue Number: P99-150-0091
• Device Lot Number: 9154952
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1