MAUDE Adverse Event Report: NOBEL BIOCARE AB REPLACE SELECT TAPERED PMC WP 5.0X16MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	37314
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/15/2022
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: REPLACE SELECT TAPERED PMC WP 5.0X16MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• MDR Report Key: 15339763
• Report Number: 2027971-2022-107098
• Device Sequence Number: 12383596
• Product Code: DZE
• UDI-Device Identifier: 07332747073355
• UDI-Public: (01)07332747073355(10)12031350(17)191018
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 09/01/2022

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: 10/18/2019
• Device Model Number: 37314
• Device Catalogue Number: 37314
• Device Lot Number: 12031350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/22/2022
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2022
• 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: 55 YR
• Patient Sex: Male
• Date Report Sent to FDA: 09/01/2022