MAUDE Adverse Event Report: DENTIUM USA IMPLANTIUM; IMPLANT, ENDOSSEOUS, ROOT-FORM

Model Number FX3410MLC

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Osteopenia/ Osteoporosis (2651)

Event Date 03/07/2015

Event Type  Injury  

Event Description

Patient developed severe bone loss 3 years 6 month after implantation of the dental implant fx3410mlc in tooth location #20.Implant was removed on (b)(6) 2015 due to bone condition and poor oral hygiene.The patient is recovered without complications.

• Brand Name: IMPLANTIUM
• Type of Device: IMPLANT, ENDOSSEOUS, ROOT-FORM
• Manufacturer (Section D): DENTIUM USA; 6761 katella ave.; cypress CA 90630
• Manufacturer (Section G): DENTIUM USA; 6761 katella ave.; cypress CA 90630
• Manufacturer Contact: younjung yuk ; 6761 katella ave.; cypress, CA 90630 ; 7142260229
• MDR Report Key: 4914070
• MDR Text Key: 6430742
• Report Number: 3005503242-2015-00016
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 07/14/2015

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
• Device Operator: Dentist
• Device Expiration Date: 12/31/2018
• Device Model Number: FX3410MLC
• Device Lot Number: L06X06H07AS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2015
• Initial Date FDA Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR