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

Model Number	E303
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2026
Type of Reportable Event	Malfunction

• Brand Name: HU-FRIEDY
• Common Device Name: #303 APEXO 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: katy peterson ; 2501 sander rd; northbrook, IL 60062 ; 8472574500
• MDR Report Key: 25779836
• Report Number: 1416605-2026-00015
• Device Sequence Number: 15859389
• Product Code: EMJ
• UDI-Device Identifier: 10889950009120
• UDI-Public: (01)10889950009120
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 07/10/2026

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
• Operator of Device: Health Professional
• Device Model Number: E303
• Device Catalogue Number: E303
• Device Lot Number: 0123
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown