MAUDE Adverse Event Report: NOBEL BIOCARE AB MULTI-UNIT ABUTMENT XEAL CC NP 1.5MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	300171
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user indicated the implant failed, however based on the available information the exact issue could not be identified.

• Brand Name: MULTI-UNIT ABUTMENT XEAL CC NP 1.5MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• MDR Report Key: 14289912
• Report Number: 2027971-2022-066660
• Device Sequence Number: 16559066
• Product Code: DZE
• UDI-Device Identifier: 07332747126471
• UDI-Public: (01)07332747126471(10)12183106(17)240802
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section F): 05/04/2022

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: 08/02/2024
• Device Model Number: 300171
• Device Catalogue Number: 300171
• Device Lot Number: 12183106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/11/2022
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2022
• 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: 76 YR
• Patient Sex: Female
• Date Report Sent to FDA: 05/04/2022