MAUDE Adverse Event Report: DENTIUM USA IMPLANTIUM; DENTAL IMPLANT

Model Number	FX3412MLC
Medical Device Problem Codes	Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Patient Problem/Medical Problem (2688)
Date of Event	03/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The doctor reported the implant was removed due to osseointegration failure 4 months after placement surgery.Bone quality was type ii and oral hygiene at the site of the implant was good.During the surgery, no significant findings were observed.The patient has recovered.
Event or Problem Description
The doctor reported the implant was removed due to osseointegration failure 4 months after placement surgery.Bone quality was type ii and oral hygiene at the site of the implant was good.During the surgery, no significant findings were observed.The patient has recovered.
Additional Manufacturer Narrative
Brand name was initially reported as "superline." correction was made to report brand name as "implantium." the pma/510k number was corrected accordingly.

• Brand Name: IMPLANTIUM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): DENTIUM USA; 6761 katella ave; cypress CA 90630
• MDR Report Key: 10498283
• Report Number: 3005503242-2020-00141
• Device Sequence Number: 2627667
• Product Code: DZE
• UDI-Device Identifier: D755FX3412MLC0
• UDI-Public: D755FX3412MLC0
• Combination Product (Y/N): Y
• 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: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2020

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: No Information
• Device Expiration Date: 12/13/2024
• Device Model Number: FX3412MLC
• Device Catalogue Number: FX3412MLC
• Device Lot Number: L08RA953S
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 09/06/2020
• Supplement Report FDA Received Date: 12/15/2020
• 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
• Patient Age: 64 YR