FDA Adverse Event Injury Summary report: N

2027971-2022-042559

MDR report key: 13551523 · Received February 17, 2022

Report

Report Number
2027971-2022-042559
Event Type
Injury
Date Received
February 17, 2022
Date of Event
February 3, 2021
Report Date
February 17, 2022
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

IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
473395 DZE NOBEL BIOCARE USA, LLC

Patients

Seq Age Sex Outcome Treatment
1 35 YR Female Required Intervention