FDA Adverse Event Injury Summary report: N

TUFF TT IMPLANT

MDR report key: 19847989 · Received July 28, 2024

Report

Report Number: 3011390931-2024-00560
Event Type: Injury
Date Received: July 28, 2024
Date of Event: June 27, 2024
Report Date: July 28, 2024
Manufacturer: NORIS MEDICAL LTD
Product Code: DZE
UDI-DI: 07290108812282
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#9000903 AND THERE WAS NO EVIDENCE DISCOVERED TO INDICATE THAT A PRODUCT DEFECT OR NON-CONFORMITY CONTRIBUTED TO THE ISSUE. 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.

Additional Manufacturer Narrative · 0

UDI RELATED DATA QUALITY UPDATES ONLY.

Description of Event or Problem · 0

A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4316 LOT#9000903 IMPLANT LACKED PRIMARY STABILITY ON TOOTH #13. THE IMPLANT WAS REMOVED DURING IMPLANT PLACEMENT WITH NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS. ACCORDING TO THE INFORMATION, THE PATIENT HAS HYPERTENSION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1528310	TUFF TT IMPLANT	TUFF TT DENTAL IMPLANT	DZE	NORIS MEDICAL LTD	NM-F4316	9000903	07290108812282

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Female