FDA Adverse Event Injury Summary report: N

UNKNOWN

MDR report key: 23836394 · Received December 18, 2025

Report

Report Number: 3027665899-2025-00001
Event Type: Injury
Date Received: December 18, 2025
Report Date: December 14, 2025
Manufacturer: INFINITUM ETA LTD.
Product Code: DZE
PMA / PMN Number: K233081
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: DENTIST
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE SPECIFIC DEVICE IDENTIFICATION (LOT/REFERENCE NUMBERS) WAS NOT PROVIDED AT THE TIME OF THIS REPORT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) COULD NOT BE PERFORMED. THE SUBJECT DEVICES HAVE NOT BEEN RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE MANUFACTURER HAS REQUESTED THE NECESSARY PRODUCT IDENTIFICATION AND THE RETURN OF THE SUBJECT DEVICES TO FACILITATE AN INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONLY IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

Description of Event or Problem · 0

NOTIFICATION RECEIVED REGARDING THREE (3) ALLEGED IMPLANT FAILURES (LOSS OF OSSEOINTEGRATION) REPORTED BY THE SAME CLINICIAN. THE REPORTER INDICATES THAT ALL THREE INCIDENTS OCCURRED WITHIN THE FIRST THREE WEEKS OF TREATMENT FOLLOWING AN IMMEDIATE EXTRACTION AND IMMEDIATE PLACEMENT PROTOCOL. NO PERMANENT PATIENT INJURY OR ADDITIONAL MEDICAL INTERVENTION BEYOND THE EXPLANTATION WAS REPORTED. THE SPECIFIC DEVICE REF AND LOT NUMBERS ARE CURRENTLY BEING VERIFIED, AND A COMPLAINT INVESTIGATION WAS INITIATED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2186896	UNKNOWN	DENTAL IMPLANT	DZE	INFINITUM ETA LTD.	WAS NOT PROVIDED	WAS NOT PROVIDED

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Required Intervention