MAUDE Adverse Event Report: BIOTECH DENTAL KONTACT; DENTAL IMPLANT

Model Number	K4212
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/07/2023
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, 1330 ; FR 1330
• MDR Report Key: 18275461
• Report Number: 3010730876-2023-00078
• Device Sequence Number: 20567097
• Product Code: DZE
• UDI-Device Identifier: 03701045271048
• UDI-Public: 03701045271048
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 12/04/2023

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: K4212
• Device Lot Number: 210902-010/N
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 2 MO
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2023
• 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: 66 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White