MAUDE Adverse Event Report: NOBEL BIOCARE AB 17° MULTI-UNIT ABUTMENT XEAL CC RP 2.5MM

Model Number	300182
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant malfunctioned due to part not functional.

• Brand Name: 17° MULTI-UNIT ABUTMENT XEAL CC RP 2.5MM
• Common Device Name: ABUTMENT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• MDR Report Key: 16964574
• Report Number: 2027971-2023-076854
• Device Sequence Number: 14800579
• Product Code: DZE
• UDI-Device Identifier: 07332747126587
• UDI-Public: (01)07332747126587(10)12212023(17)251028
• 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): 05/19/2023

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 Expiration Date: 10/28/2025
• Device Model Number: 300182
• Device Catalogue Number: 300182
• Device Lot Number: 12212023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/02/2023
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2023
• 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: 60 YR
• Patient Sex: Female
• Date Report Sent to FDA: 05/19/2023