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

Model Number 300251

Device Problems Failure to Osseointegrate (1863); Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 06/23/2023

Event Type  Injury  

Event Description

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

Manufacturer Narrative

The initial report did not have the correct event type documented, the correct event type, serious injury, is provided in this follow-up report.

Event Description

The implant malfunctioned due to an engagement issue.The malfunction did not cause or contribute to a death or serious injury.The initial report did not have the correct event type documented, the correct event type, serious injury, is provided in this follow-up report.

• Brand Name: NOBELACTIVE TIULTRA RP 4.3X10MM
• 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: 17271862
• MDR Text Key: 318503586
• Report Number: 9611993-2023-084668
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K202344
• 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,Followup

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 300251
• Device Catalogue Number: 300251
• Device Lot Number: 12220487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2023
• 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: 62 YR
• Patient Sex: Male