MAUDE Adverse Event Report: BIOTECH DENTAL KONTACT; DENTAL IMPLANT

Model Number	K4208
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to dr.(b)(6), the dental implant was placed on (b)(6) 2025.The patient returned for follow-up on (b)(6) 2025, at which time clinical examination revealed an abscess with purulent discharge at the implant site.Incision and drainage were performed, and the patient was prescribed antibiotics.The patient presented again on (b)(6) 2025, reporting that on the morning of (b)(6) 2025, she felt the implant begin to loosen, and by that evening, she could no longer feel it in her mouth.The patient stated that she was uncertain whether she inadvertently swallowed the implant.A periapical radiograph confirmed the absence of the implant.

• 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: 22613211
• Report Number: 3010730876-2025-00049
• Device Sequence Number: 5418856
• Product Code: DZE
• UDI-Device Identifier: 03701045271024
• UDI-Public: (01)03701045271024(10)240605-009/P
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 07/25/2025

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: K4208
• Device Lot Number: 240605-009/P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/23/2025
• Device Age: 1 MO
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2025
• 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: 49 YR
• Patient Sex: Female