FDA Adverse Event Injury Summary report: N

2027971-2022-052665

MDR report key: 13844146 · Received March 21, 2022

Report

Report Number
2027971-2022-052665
Event Type
Injury
Date Received
March 21, 2022
Date of Event
March 7, 2022
Report Date
March 21, 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

PRODUCT FAILED DO TO AN INABILITY TO SEPARATE COMPONENTS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
548256 DZE NOBEL BIOCARE USA, LLC

Patients

Seq Age Sex Outcome Treatment
1 44 YR Male Required Intervention