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

Model Number 300251

Device Problem Defective Device (2588)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Date 03/02/2023

Event Type  Injury  

Event Description

Implant failed due to "part/interface does not fit/align".

Event Description

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

Manufacturer Narrative

The initial report did not have the correct event type documented, the correct event type, 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: 16726865
• MDR Text Key: 313158197
• Report Number: 9611993-2023-057540
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 07332747127423
• UDI-Public: (01)07332747127423(10)12209098(17)270917
• 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,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: 12209098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/19/2022
• 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: 40 YR
• Patient Sex: Prefer Not To Disclose