MAUDE Adverse Event Report: Biotech Dental Kontact; Dental Implant

Model Number	K3608
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/15/2026
Type of Reportable Event	Serious Injury

• Brand Name: Kontact
• Common Device Name: Dental Implant
• Manufacturer (Section D): Biotech Dental; 305 allees craponne; salon-de-provence 13300 ; FR 13300
• MDR Report Key: 50722673
• Report Number: 3010730876-2026-00025
• Device Sequence Number: 10159578
• Product Code: DZE
• UDI-Device Identifier: 03701045270966
• UDI-Public: (01)03701045270966(10)230222-071/O
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/10/2026
• Report Date (Section F): 09/10/2026

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: K3608
• Device Lot Number: 230222-071/O
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/31/2026
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2026
• 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: 55 YR
• Patient Sex: Male
• Patient Race: Black Or African American