MAUDE Adverse Event Report: BIOTECH DENTAL KONTACT; DENTAL IMPLANT

Model Number	K4810
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed due to failure to osseointegrate.

• Brand Name: KONTACT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOTECH DENTAL; 305 allee de craponne; salon-de-provence, 13300 ; FR 13300
• MDR Report Key: 19557996
• Report Number: 3010730876-2024-00054
• Device Sequence Number: 14636207
• Product Code: DZE
• UDI-Device Identifier: 03701045271093
• UDI-Public: 03701045271093
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 06/14/2024

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 Model Number: K4810
• Device Lot Number: 211029-125/N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/20/2024
• Device Age: 3 MO
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2024
• 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: 53 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White