MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC 303 APEXO ELEVATOR

Model Number E303

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 04/04/2020

Event Type  malfunction  

Manufacturer Narrative

The lot number or model of the device subject of the event was not provided.A follow-up mdr will be submitted should additional information become available.

Event Description

Hu-friedy was notified of a complaint where the tip of a dental elevator detached in a patient's mouth during a dental procedure on (b)(6) 2020.The tip of the dental elevator was removed from the patient's jaw during a subsequent procedure.

• Brand Name: 303 APEXO ELEVATOR
• Type of Device: ELEVATOR
• Manufacturer (Section D): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st.; chicago IL 60618
• Manufacturer (Section G): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st.; chicago IL 60618
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 14416714
• MDR Text Key: 291858395
• Report Number: 1416605-2022-00005
• Device Sequence Number: 1
• Product Code: EMJ
• UDI-Device Identifier: 10889950009120
• UDI-Public: 10889950009120
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: E303
• Device Catalogue Number: E303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 05/17/2022
• Supplement Dates Manufacturer Received: 03/22/2022; 03/22/2022
• Supplement Dates FDA Received: 08/01/2023; 04/11/2024
• 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