MAUDE Adverse Event Report: NOBEL BIOCARE AB GÖTEBORG NOBELPARALLEL CC TIULTRA RP 4.3X18MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	300308
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Loss of osseointegration.
Event or Problem Description
Loss of osseointegration the material number has been updated.The corrected information is provided in this follow up report.

• Brand Name: NOBELPARALLEL CC TIULTRA RP 4.3X18MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB GÖTEBORG; västra hamngatan 1; göteborg 41117 ; SW 41117
• MDR Report Key: 23090244
• Report Number: 2027971-2025-126042
• Device Sequence Number: 18763008
• Product Code: DZE
• UDI-Device Identifier: 07332747128086
• UDI-Public: (01)07332747128086(10)12139272(17)240718
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section F): 09/18/2025

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 Expiration Date: 07/18/2024
• Device Catalogue Number: 300308
• Device Lot Number: 12139272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/10/2025
• Event Location: Outpatient Treatment Facility
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 04/10/2026
• 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: 41 YR
• Patient Sex: Female
• Date Report Sent to FDA: 09/18/2025