FDA Adverse Event Injury Summary report: N

2027971-2024-132679

MDR report key: 20422469 · Received October 10, 2024

Report

Report Number
2027971-2024-132679
Event Type
Injury
Date Received
October 10, 2024
Date of Event
October 12, 2023
Report Date
October 10, 2024
Manufacturer
NOBEL BIOCARE USA, LLC
Product Code
DZE
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
US
Reporter Occupation
DENTIST
Health Professional
Yes

Narratives

Description of Event or Problem · 0

IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
324915 DZE NOBEL BIOCARE USA, LLC

Patients

Seq Age Sex Outcome Treatment
1 45 YR Male Required Intervention