MAUDE Adverse Event Report: BIOTECH DENTAL KONTACT; DENTAL IMPLANT

Model Number	K3612
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/13/2023
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 allees de craponne; salon-de-provence 13300 ; FR 13300
• MDR Report Key: 17645746
• Report Number: 3010730876-2023-00046
• Device Sequence Number: 17562774
• Product Code: DZE
• UDI-Device Identifier: 03701045270980
• UDI-Public: 03701045270980
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 08/29/2023

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: K3612
• Device Lot Number: 210903-028/N
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2023
• 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: 83 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White