MAUDE Adverse Event Report: Nobel Biocare AB NobelActive Internal NP 3.5x10mm; Endosseous Dental Implant

Catalog Number	34125
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury

• Brand Name: NobelActive Internal NP 3.5x10mm
• Common Device Name: Endosseous Dental Implant
• Manufacturer (Section D): Nobel Biocare AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• MDR Report Key: 50925436
• Report Number: 2027971-2026-133196
• Device Sequence Number: 12200780
• Product Code: DZE
• UDI-Device Identifier: 07332747160024
• UDI-Public: (01)07332747160024(10)13192254(17)300519
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/28/2026
• Report Date (Section F): 09/28/2026

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: 34125
• Device Lot Number: 13192254
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/24/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/20/2026
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2026
• 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: 43 YR
• Patient Sex: Male