MAUDE Adverse Event Report: NOBEL BIOCARE AB BMK SYST ZYGOMA 17° MULTI-UNIT ABUT 2MM; ABUTMENT

Catalog Number	32328
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Part fractured.

• Brand Name: BMK SYST ZYGOMA 17° MULTI-UNIT ABUT 2MM
• Common Device Name: ABUTMENT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• MDR Report Key: 20362681
• Report Number: 2027971-2024-129927
• Device Sequence Number: 15448499
• Product Code: DZE
• UDI-Device Identifier: 07332747003147
• UDI-Public: (01)07332747003147(10)12161049(17)230905
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section F): 10/03/2024

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: 09/05/2023
• Device Catalogue Number: 32328
• Device Lot Number: 12161049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/27/2024
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2024
• 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: 75 YR
• Patient Sex: Female
• Date Report Sent to FDA: 10/03/2024