FDA Adverse Event Injury Summary report: N

TUFF IMPLANT

MDR report key: 21728509 · Received March 30, 2025

Report

Report Number: 3011390931-2025-00194
Event Type: Injury
Date Received: March 30, 2025
Date of Event: February 12, 2025
Report Date: March 30, 2025
Manufacturer: NORIS MEDICAL LTD
Product Code: DZE
UDI-DI: 07290108812176
PMA / PMN Number: K140440
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# 9001144 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) 2024. ON (B)(6) 2025, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED ON TOOTH #19. ACCORDING TO THE INFORMATION, THE PATIENT HAS HYPERTENSION, BRUXISM, OSTEOPOROSIS, THYROID THERAPY. OBSERVED DURING THE EVENT: MOBILITY. A SECONDARY IMPLANT WAS PLACED AFTER REMOVAL. 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
751137	TUFF IMPLANT	TUFF DENTAL IMPLANT	DZE	NORIS MEDICAL LTD	NM-F4210	9001144	07290108812176

Patients

Seq	Age	Sex	Outcome	Treatment
1	74 YR	Female