FDA Adverse Event Injury Summary report: N

2027971-2022-030494

MDR report key: 13231087 · Received January 11, 2022

Report

Report Number
2027971-2022-030494
Event Type
Injury
Date Received
January 11, 2022
Date of Event
January 7, 2022
Report Date
January 11, 2022
Manufacturer
NOBEL BIOCARE USA, LLC
Product Code
DZE
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
FR
Reporter Occupation
DENTIST
Health Professional
Yes

Narratives

Description of Event or Problem · 0

IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
941205 DZE NOBEL BIOCARE USA, LLC

Patients

Seq Age Sex Outcome Treatment
1 82 YR Male Required Intervention