FDA Adverse Event Injury Summary report: N

NOBELPARALLEL CC TIULTRA RP 4.3X13MM

MDR report key: 18175346 · Received November 20, 2023

Report

Report Number
2027971-2023-144100
Event Type
Injury
Date Received
November 20, 2023
Date of Event
November 3, 2023
Report Date
November 20, 2023
Manufacturer
NOBEL BIOCARE AB
Product Code
DZE
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
RS
Reporter Occupation
DENTIST
Health Professional
Yes

Narratives

Description of Event or Problem · 0

IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION (B)(6) 2023 14:22:24 CET (5023852). USER:5023852 RECEIVED DATE OF THE RETURN PRODUCT:20/11/2023.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2164918 NOBELPARALLEL CC TIULTRA RP 4.3X13MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB

Patients

Seq Age Sex Outcome Treatment
1 Female Required Intervention