MAUDE Adverse Event Report: A.B. DENTAL DEVICES LTD. TITAN IMPLANT/CONICAL IMPALNT; ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Model Number I5

Device Problem Break (1069)

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

Event Date 03/30/2017

Event Type  Injury  

Event Description

Broken implant.After 9 years of the implant in the patient mouth the implant broke due to bone resorption expected and foreseeable side effect.Fda safety report id # (b)(4).

• Brand Name: TITAN IMPLANT/CONICAL IMPALNT
• Type of Device: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): A.B. DENTAL DEVICES LTD.; ashdod
• MDR Report Key: 9653169
• MDR Text Key: 177554119
• Report Number: MW5092634
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 07290107270410
• UDI-Public: 07290107270410
• Combination Product (y/n): N
• 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: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Model Number: I5
• Device Catalogue Number: I5-3.75, 10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention