MAUDE Adverse Event Report: NOBEL BIOCARE AB GÖTEBORG NOBELREPLACE S TIUNITE NP 4.3X11.5MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	302403
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Lack of stability during placement.

• Brand Name: NOBELREPLACE S TIUNITE NP 4.3X11.5MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB GÖTEBORG; västra hamngatan 1; göteborg 41117 ; SW 41117
• MDR Report Key: 25614464
• Report Number: 2027971-2026-096016
• Device Sequence Number: 18395306
• Product Code: DZE
• UDI-Device Identifier: 07332747223248
• UDI-Public: (01)07332747223248(10)12282759(17)301203
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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 F): 06/24/2026

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 Catalogue Number: 302403
• Device Lot Number: 12282759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/16/2026
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Date Report Sent to FDA: 06/24/2026