MAUDE Adverse Event Report: NOBEL BIOCARE AB GÖTEBORG MULTI-UNIT ABUTMENT XEAL CC RP 3.5MM

Catalog Number	300178
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Foreign particles on the product/in pack.

• Brand Name: MULTI-UNIT ABUTMENT XEAL CC RP 3.5MM
• Common Device Name: ABUTMENT
• Manufacturer (Section D): NOBEL BIOCARE AB GÖTEBORG; bohusgatan 15; göteborg 41139 ; SW 41139
• MDR Report Key: 21308902
• Report Number: 2027971-2025-041315
• Device Sequence Number: 8083763
• Product Code: DZE
• UDI-Device Identifier: 07332747188219
• UDI-Public: (01)07332747188219(10)12250027(17)270804
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section F): 02/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 300178
• Device Lot Number: 12250027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/28/2025
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2025
• 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 Sex: Unknown
• Date Report Sent to FDA: 02/04/2025