MAUDE Adverse Event Report: DENTIUM USA IMPLANTIUM; DENTAL IMPLANT

Model Number	FX3810MLC
Medical Device Problem Codes	Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Osseointegration (2646); Patient Problem/Medical Problem (2688)
Date of Event	10/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The doctor reported that implant was removed due to loss of osseointegration approximately 1 year and 6 months since the date of surgery.Bone type observed in the are was type 1, and oral hygiene around the site of surgery was moderate.During the surgery, peri-implantitis was observed.Patient has recovered since.
Event or Problem Description
The doctor reported that implant was removed due to loss of osseointegration approximately 1 year and 6 months since the date of surgery.Bone type observed in the are was type 1, and oral hygiene around the site of surgery was moderate.During the surgery, peri-implantitis was observed.Patient has recovered since.
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: 10738266
• Report Number: 3005503242-2020-00165
• Device Sequence Number: 11592717
• Product Code: DZE
• UDI-Device Identifier: D755FX3810MLC0
• UDI-Public: D755FX3810MLC0
• 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): 10/26/2020

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: 02/19/2026
• Device Model Number: FX3810MLC
• Device Catalogue Number: FX3810MLC
• Device Lot Number: B15PB291S
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 10/26/2020
• 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: 69 YR