FDA Adverse Event Injury Summary report: N

TUFF UNICON IMPLANT

MDR report key: 24993442 · Received April 26, 2026

Report

Report Number: 3011390931-2026-00119
Event Type: Injury
Date Received: April 26, 2026
Date of Event: February 26, 2026
Report Date: April 26, 2026
Manufacturer: NORIS MEDICAL LTD
Product Code: DZE
UDI-DI: 07290116154732
PMA / PMN Number: K240202
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: DENTIST
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE DHR WAS REVIEWED FOR LOT # 9001523 AND THERE WAS NO EVIDENCE DISCOVERED TO INDICATE THAT A PRODUCT DEFECT OR NON-CONFORMITY CONTRIBUTED TO THE ISSUE. TO DATE, ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. THE INVESTIGATION FOR THIS EVENT HAS NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. OUR MANUFACTURING SYSTEM ASSURES, THAT PRODUCTION AND PROCESS CONTROLS ARE IN PLACE TO ENSURE THAT BATCHES CONFORM TO THE APPLICABLE SPECIFICATIONS BEFORE THEY ARE DISTRIBUTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 0

THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025. ON (B)(6) 2026, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. ACCORDING TO THE INFORMATION, THE PATIENT HAS HYPERTENSION, PERIODONTITIS. AT THE EVENT, THE PATIENT EXPERIENCED: PAIN. OBSERVED DURING THE EVENT: MOBILITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1054209	TUFF UNICON IMPLANT	TUFF UNICON DENTAL IMPLANT	DZE	NORIS MEDICAL LTD	NMCF5508	9001523	07290116154732

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR	Male