MAUDE Adverse Event Report: DENTIUM USA IMPLANTIUM; DENTAL IMPLANT

Model Number	FX4310MLC
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Osseointegration (2646)
Date of Event	12/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per submission summary error_message "2688 is an invalid health effect - clinical code," the following code was removed from this report.Internal data has also been updated to remove the code from list.
Event or Problem Description
The doctor reported that the implant was removed due osseointegration failure approximately 11 months after initial implant placement.Bone quality around the area was type 3, and oral hygiene around the implant was moderate.During the surgery, no significant findings were observed.Pt.Has recovered since.

• Brand Name: IMPLANTIUM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): DENTIUM USA; 6761 katella ave; cypress CA 90630
• MDR Report Key: 11536697
• Report Number: 3005503242-2021-00031
• Device Sequence Number: 16885581
• Product Code: DZE
• UDI-Device Identifier: D755FX4310MLC0
• UDI-Public: D755FX4310MLC0
• 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): Y
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/05/2021

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: 02/05/2026
• Device Model Number: FX4310MLC
• Device Catalogue Number: FX4310MLC
• Device Lot Number: A18PB273S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 03/20/2021
• 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: 56 YR