MAUDE Adverse Event Report: NOBEL BIOCARE AB NOBELACTIVE TIULTRA RP 4.3X11.5MM; ENDOSSEOUS DENTAL IMPLANT

Model Number 300252

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 02/07/2023

Event Type  Injury  

Event Description

Implant failed due to a "part/interface does not engage".

• Brand Name: NOBELACTIVE TIULTRA RP 4.3X11.5MM
• 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: 16692547
• MDR Text Key: 312810449
• Report Number: 9611993-2023-056361
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 07332747127430
• UDI-Public: (01)07332747127430(10)12204711(17)270716
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 300252
• Device Catalogue Number: 300252
• Device Lot Number: 12204711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/17/2022
• 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: 71 YR
• Patient Sex: Female