MAUDE Adverse Event Report: NOBEL BIOCARE AB GÖTEBORG TREFOIL IMPLANT CC RP 5.0X11.5+4.5MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	38320
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Loss of osseointegration.

• Brand Name: TREFOIL IMPLANT CC RP 5.0X11.5+4.5MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB GÖTEBORG; bohusgatan 15; göteborg 41139 ; SW 41139
• MDR Report Key: 22406522
• Report Number: 2027971-2025-098252
• Device Sequence Number: 21248863
• Product Code: DZE
• UDI-Device Identifier: 07332747161663
• UDI-Public: (01)07332747161663(10)12181638(17)260716
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section F): 07/05/2025

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: 07/16/2026
• Device Catalogue Number: 38320
• Device Lot Number: 12181638
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/30/2025
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/04/2025
• 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: 71 YR
• Patient Sex: Female
• Date Report Sent to FDA: 07/05/2025