FDA Adverse Event Death Summary report: N

NOBELPARALLEL CC RP 4.3X8.5MM

MDR report key: 15634283 · Received October 19, 2022

Report

Report Number
9611993-2022-103630
Event Type
Death
Date Received
October 19, 2022
Date of Event
July 7, 2022
Manufacturer
NOBEL BIOCARE AB
Product Code
DZE
UDI-DI
07332747161267
PMA / PMN Number
K173418
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CH
Reporter Occupation
DENTIST
Health Professional
Yes

Narratives

Description of Event or Problem · 0

IMPLANT FAILED DUE TO OSSEOINTEGRATION PROBLEM.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2047040 NOBELPARALLEL CC RP 4.3X8.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 37971 12170703 07332747161267

Patients

Seq Age Sex Outcome Treatment
1 49 YR Male Required Intervention