FDA Adverse Event Injury Summary report: N

INFINITY OCTAGON

MDR report key: 22737242 · Received August 7, 2025

Report

Report Number
1287163-2025-02402
Event Type
Injury
Date Received
August 7, 2025
Date of Event
June 30, 2025
Report Date
August 7, 2025
Manufacturer
HAGER & MEISINGER GMH
Product Code
DZE
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
MA, US
Reporter Occupation
DENTIST
Health Professional
Yes

Narratives

Description of Event or Problem · 0

FAILURE TO OSEOINTEGRATE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2006328 INFINITY OCTAGON DENTAL IMPLANT DZE HAGER & MEISINGER GMH 504810BL

Patients

Seq Age Sex Outcome Treatment
1 68 YR Male Required Intervention