MAUDE Adverse Event Report: Nobel Biocare AB Göteborg NobelActive Internal NP 3.5x8.5mm; Endosseous Dental Implant

Catalog Number	35221
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2026
Type of Reportable Event	Serious Injury

• Brand Name: NobelActive Internal NP 3.5x8.5mm
• Common Device Name: Endosseous Dental Implant
• Manufacturer (Section D): Nobel Biocare AB Göteborg; västra hamngatan 1; göteborg 41117 ; SW 41117
• Manufacturer (Section G): Nobel Biocare AB Göteborg; västra hamngatan 1; göteborg 41117 ; SW 41117
• Manufacturer Contact: gayco meel ; heierkerweg 1b; venlo 5928 -RM ; NL 5928 RM ; +031()623202508
• MDR Report Key: 50940109
• Report Number: 9611993-2026-136052
• Device Sequence Number: 10735014
• Product Code: DZE
• UDI-Device Identifier: 07332747160260
• UDI-Public: (01)07332747160260(10)12276759(17)300923
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K083205
• 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: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 35221
• Device Lot Number: 12276759
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/24/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female