MAUDE Adverse Event Report: NOBEL BIOCARE AB NOBELPARALLEL CC NP 3.75X11.5MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number 37966

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 01/25/2024

Event Type  Injury  

Event Description

Implant failed due to engagement issue.

• Brand Name: NOBELPARALLEL CC NP 3.75X11.5MM
• Type of Device: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• MDR Report Key: 18715261
• MDR Text Key: 335495542
• Report Number: 2027971-2024-044853
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 37966
• Device Lot Number: 12229940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 02/15/2024
• Distributor Facility Aware Date: 01/29/2024
• 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: 74 YR
• Patient Sex: Male