MAUDE Adverse Event Report: DENTIUM USA IMPLANTIUM; DENTAL IMPLANT

Model Number	FX3412MLC
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/11/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The dental implant fx3412mlc was removed on (b)(6) 2017 due to an implant fracture 1 year and 5 months after implantation.The patient has no significant medical history.The patient has recovered without complications.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The dental implant fx3412mlc was removed on (b)(6) 2017 due to an implant fracture 1 year and 5 months after implantation.The patient has no significant medical history.The patient has recovered without complications.

• Brand Name: IMPLANTIUM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): DENTIUM USA; 6761 katella ave; cypress CA 90630
• MDR Report Key: 7310024
• Report Number: 3005503242-2018-00047
• Device Sequence Number: 1355152
• Product Code: DZE
• UDI-Device Identifier: D755FX3412MLC0
• UDI-Public: D755FX3412MLC0
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K041368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2018

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: Dentist
• Device Expiration Date: 07/31/2020
• Device Model Number: FX3412MLC
• Device Catalogue Number: FX3412MLC
• Device Lot Number: G13VA562S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 05/04/2018
• 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
• Patient Age: 58 YR