MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC DENTAL IMPLANT; IMPLANT, ENDOSSEOUS, ROOT-FORM

Model Number LEGACY 3

Device Problems Break (1069); Product Quality Problem (1506); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 05/02/2023

Event Type  malfunction  

Event Description

In 2013 i had a dental implant placed on tooth #19.Around 2 years ago, the crown became loose.I immediately went to dentist-crown was removed and screw was tightened.This happened several times over the course of two years-each time going to dentist.The screw was eventually replaced.Around the end of (b)(6) 2023, i started to have lower jaw pain.I went to the dentist on (b)(6) 2023.The dentist removed crown and took xray.The xray showed that the post was broken.I was sent to the same oral surgeon who did the original implant surgery.I was informed device would have to be removed and no way to save it.The faulty device was removed (b)(6) 2023.The removal was due to equipment failure and not gum disease or other dental issues.The removal of the implant was quite different than the placing of the device.The bone had fused well with the implant.The surgeon had to drill around the implant to remove from the bone.This also required a bone graft.I have been informed that the removal of an implant due to equipment failure is quite rare.This device was from implant direct.Implant type-legacy 3.Implant size 3.7x11.5 ref #853711.Reference report: mw5117984, mw5117985, mw5117986.

• Brand Name: DENTAL IMPLANT
• Type of Device: IMPLANT, ENDOSSEOUS, ROOT-FORM
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC
• MDR Report Key: 17030764
• MDR Text Key: 316251681
• Report Number: MW5117983
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• 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: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: LEGACY 3
• Device Catalogue Number: 853711
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/30/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic