MAUDE Adverse Event Report: NOBEL BIOCARE AB NOBELACTIVE WP 5.5X15MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	37811
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	05/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed due to a loss of osseointegration.

• Brand Name: NOBELACTIVE WP 5.5X15MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• MDR Report Key: 19401891
• Report Number: 2027971-2024-083965
• Device Sequence Number: 15544818
• Product Code: DZE
• UDI-Device Identifier: 07332747088342
• UDI-Public: (01)07332747088342(10)12087226(17)220430
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 05/27/2024

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: 04/30/2022
• Device Catalogue Number: 37811
• Device Lot Number: 12087226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/24/2024
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2024
• 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: 73 YR
• Patient Sex: Female
• Date Report Sent to FDA: 05/27/2024