MAUDE Adverse Event Report: BIOTECH DENTAL KONTACT; DENTAL IMPLANT

Model Number	K5008-42S
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The implant was mobile when removing the cover screw for the first time at uncovery.Implant did not integrate and was removed with reverse finger torque with cover screw still fully seated.

• 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: 24619958
• Report Number: 3010730876-2026-00012
• Device Sequence Number: 9640148
• Product Code: DZE
• UDI-Device Identifier: 03701045273721
• UDI-Public: (01)03701045273721(10)230106-032/C
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 03/17/2026

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: K5008-42S
• Device Lot Number: 230106-032/C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/10/2026
• Device Age: 6 MO
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2026
• 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: 46 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White