FDA Adverse Event Injury Summary report: N

PTERYFIT IMPLANT

MDR report key: 19348463 · Received May 19, 2024

Report

Report Number: 3011390931-2024-00152
Event Type: Injury
Date Received: May 19, 2024
Date of Event: November 21, 2023
Report Date: May 19, 2024
Manufacturer: NORIS MEDICAL LTD
Product Code: DZE
UDI-DI: 07290108817133
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#9000649 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

THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023. ON (B)(6) 2023, LOOSENING OF IMPLANT NOT RELATED TO BONE INGROWTH WAS VERIFIED. ACCORDING TO THE INFORMATION, THE PATIENT IS HEALTHY. OBSERVED DURING THE EVENT: INFECTION. 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
1616017	PTERYFIT IMPLANT	PTERYFIT DENATL IMPLANT	DZE	NORIS MEDICAL LTD	NMAF4225	9000649	07290108817133

Patients

Seq	Age	Sex	Outcome	Treatment
1	60 YR	Female