FDA Adverse Event Injury Summary report: N

NOBELREPLACE CC PMC NP 3.5X10MM

MDR report key: 19876576 · Received July 31, 2024

Report

Report Number
2027971-2024-107628
Event Type
Injury
Date Received
July 31, 2024
Date of Event
May 13, 2024
Report Date
July 31, 2024
Manufacturer
NOBEL BIOCARE AB
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
835547 NOBELREPLACE CC PMC NP 3.5X10MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB

Patients

Seq Age Sex Outcome Treatment
1 40 YR Female Required Intervention