MAUDE Adverse Event Report: NOBEL BIOCARE AB MULTI-UNIT ABUTMENT XEAL CC RP 1.5MM

Model Number	300172
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Product failed do to an inability to separate components.

• Brand Name: MULTI-UNIT ABUTMENT XEAL CC RP 1.5MM
• Common Device Name: ABUTMENT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• MDR Report Key: 12799098
• Report Number: 2027971-2021-129113
• Device Sequence Number: 5718505
• Product Code: DZE
• UDI-Device Identifier: 07332747126488
• UDI-Public: (01)07332747126488(10)12171679(17)240206
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section F): 11/11/2021

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: 02/06/2024
• Device Model Number: 300172
• Device Catalogue Number: 300172
• Device Lot Number: 12171679
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/08/2021
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2021
• 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: 46 YR
• Patient Sex: Male
• Date Report Sent to FDA: 11/11/2021