FDA Adverse Event Injury Summary report: N

TUFF IMPLANT

MDR report key: 19295716 · Received May 12, 2024

Report

Report Number: 3011390931-2024-00103
Event Type: Injury
Date Received: May 12, 2024
Date of Event: March 26, 2024
Report Date: May 12, 2024
Manufacturer: NORIS MEDICAL LTD
Product Code: DZE
UDI-DI: 07290108812107
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#9000643 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.

Additional Manufacturer Narrative · 0

UDI RELATED DATA QUALITY UPDATES ONLY.

Description of Event or Problem · 0

A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F3711 LOT#9000643 IMPLANT LACKED PRIMARY STABILITY. 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
743023	TUFF IMPLANT	TUFF DENTAL IMPLANT	DZE	NORIS MEDICAL LTD	NM-F3711	9000643	07290108812107

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR	Female