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

Model Number	I5
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/30/2017
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): A.B. DENTAL DEVICES LTD.; ashdod
• MDR Report Key: 9653169
• Report Number: MW5092634
• Device Sequence Number: 11460947
• Product Code: NHA
• UDI-Device Identifier: 07290107270410
• UDI-Public: 07290107270410
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2017
• Reporter Type: Voluntary
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/28/2020

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?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention