MAUDE Adverse Event Report: NOBEL BIOCARE AB TREFOIL IMPLANT CC RP 5.0X11.5+6MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	38318
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed due to a failure to osseointegrate.

• Brand Name: TREFOIL IMPLANT CC RP 5.0X11.5+6MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• MDR Report Key: 19139347
• Report Number: 2027971-2024-069927
• Device Sequence Number: 9437932
• Product Code: DZE
• UDI-Device Identifier: 07332747161649
• UDI-Public: (01)07332747161649(10)12125772(17)231215
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section F): 04/18/2024

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: 12/15/2023
• Device Catalogue Number: 38318
• Device Lot Number: 12125772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/17/2024
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2024
• 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: 59 YR
• Patient Sex: Male
• Date Report Sent to FDA: 04/18/2024