MAUDE Adverse Event Report: NOBEL BIOCARE AB 17° MULTI-UNIT ABUTMENT XEAL CC NP 3.5MM; CLINICAL INSTRUMENT

Catalog Number	300184
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed due to dropped from the implant drive.

• Brand Name: 17° MULTI-UNIT ABUTMENT XEAL CC NP 3.5MM
• Common Device Name: CLINICAL INSTRUMENT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• MDR Report Key: 19540832
• Report Number: 2027971-2024-091856
• Device Sequence Number: 7575029
• Product Code: DZE
• UDI-Device Identifier: 07332747126600
• UDI-Public: (01)07332747126600(10)12239128(17)270205
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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

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 Catalogue Number: 300184
• Device Lot Number: 12239128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/07/2024
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/14/2024
• 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 Sex: Unknown