MAUDE Adverse Event Report: MEGAGEN AMERICA ANYONE DENTAL IMPLANT SYSTEM; ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Model Number ANYONE 3.5

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/07/2020

Event Type  Injury  

Event Description

Catastrophic vertical fracture of implant head, at its weakest point, the apex of internal hex connection, after being in function for a short duration.Fda safety report id # (b)(4).

• Brand Name: ANYONE DENTAL IMPLANT SYSTEM
• Type of Device: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): MEGAGEN AMERICA; englewood cliffs NJ 07632
• MDR Report Key: 10718620
• MDR Text Key: 212762903
• Report Number: MW5097396
• Device Sequence Number: 1
• Product Code: NHA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2020
• Device Model Number: ANYONE 3.5
• Device Catalogue Number: IF3510C
• Device Lot Number: 150617A0441-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 70 YR