MAUDE Adverse Event Report: NOBEL BIOCARE AB NOBELREPLACE CC TIULTRA RP 4.3X10MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number 300343

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 03/21/2024

Event Type  Injury  

Event Description

Implant failed due to engagement issue.

• Brand Name: NOBELREPLACE CC TIULTRA RP 4.3X10MM
• Type of Device: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• MDR Report Key: 19109431
• MDR Text Key: 340187549
• Report Number: 2027971-2024-067529
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 07332747128345
• UDI-Public: (01)07332747128345(10)12212873(17)271107
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 300343
• Device Lot Number: 12212873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/28/2024
• Event Location: Outpatient Treatment Facility
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male