MAUDE Adverse Event Report: MEGAGEN IMPLANT CO., LTD. IMPLANT; ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Model Number ANYONE 3.5

Device Problem Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Date 11/26/2018

Event Type  Injury  

Event Description

I had an implant placed, it fractured and destroyed some of the bone around the implant, and i had to have another surgery to remove implant and add bone.This also was connected to a bridge that had to be removed and will have to be replaced.After it's healed i am going to have another surgery to have another implant placed in that position.I was notified, by my dentist, that i am not the only patient that this has happened to.Fda safety report id# (b)(4).

• Brand Name: IMPLANT
• Type of Device: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): MEGAGEN IMPLANT CO., LTD.
• MDR Report Key: 10836628
• MDR Text Key: 216329762
• Report Number: MW5097831
• 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: Patient
• Type of Report: Initial
• Report Date: 11/09/2020

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?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/22/2020
• Device Model Number: ANYONE 3.5
• Device Catalogue Number: IF3513C
• Device Lot Number: 150624A0312-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 86 YR