MAUDE Adverse Event Report: NOBEL BIOCARE AB NOBEL BIOCARE N1 TIULTRA TCC RP 4.0X13MM; ENDOSSEOUS DENTAL IMPLANT

Model Number 300863

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 04/03/2023

Event Type  malfunction  

Event Description

The implant malfunctioned due to an engagement issue.The malfunction did not cause or contribute to a death or serious injury.

• Brand Name: NOBEL BIOCARE N1 TIULTRA TCC RP 4.0X13MM
• Type of Device: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• Manufacturer (Section G): NOBEL BIOCARE AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• Manufacturer Contact: gayco meel ; popeweg 72; venlo 5928 -SC ; NL 5928 SC ; 623202508
• MDR Report Key: 16771577
• MDR Text Key: 313603853
• Report Number: 9611993-2023-059687
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 07332747161755
• UDI-Public: (01)07332747161755(10)12175029(17)260320
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K211109
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 300863
• Device Catalogue Number: 300863
• Device Lot Number: 12175029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male