FDA Adverse Event Injury Summary report: N

2027971-2025-052321

MDR report key: 21541249 · Received March 6, 2025

Report

Report Number
2027971-2025-052321
Event Type
Injury
Date Received
March 6, 2025
Date of Event
January 12, 2025
Report Date
March 6, 2025
Manufacturer
NOBEL BIOCARE USA, LLC
Product Code
DZE
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
CH
Reporter Occupation
DENTIST
Health Professional
Yes

Narratives

Description of Event or Problem · 0

FAILURE TO OSSEOINTEGRATE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2313626 DZE NOBEL BIOCARE USA, LLC

Patients

Seq Age Sex Outcome Treatment
1 54 YR Male Required Intervention