FDA Adverse Event Malfunction Summary report: N

ORTHALIGN PLUS SYSTEM

MDR report key: 11904394 · Received May 28, 2021

Report

Report Number: 3007521480-2021-00006
Event Type: Malfunction
Date Received: May 28, 2021
Date of Event: April 28, 2021
Report Date: August 31, 2021
Manufacturer: ORTHALIGN, INC.
Product Code: OLO
UDI-DI: 00810832030072
PMA / PMN Number: K172462
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

THE ROOT CAUSE ACCORDING TO THE NAV. UNIT LOG FILE IS MOST LIKELY DUE TO THE RS5 SENSOR BEING UNSTABLE IN COMMUNICATION CHECK AND THE DATA RECEIVED BEING ABNORMAL. THE NAVIGATION UNIT PASSED ALL RELATED FUNCTIONAL TESTS AND FUNCTIONED AS DESIGNED WHEN USED DURING IN-HOUSE FUNCTIONAL TESTING WITH AN IN-HOUSE RS5. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ORTHALIGN, INC. WILL CONTINUE TO MONITOR THIS ISSUE AND TAKE ACTION WHEN/IF ALERT LIMITS ARE EXCEEDED.

Additional Manufacturer Narrative · 1

AT THIS TIME THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION. ONCE THE PRODUCT IS RETURNED ORTHALIGN WILL PERFORM AN INVESTIGATION INTO THE ALLEGED ACCURACY ISSUE. ORTHALIGN IS FILING THIS MDR WITH AN ABUNDANCE OF CAUTION WITH THE UNDERSTANDING OF THE POTENTIAL HARM THAT THE PATIENT COULD BE SUBJECT TO IF THE DEVICE PRODUCES INACCURATE MEASUREMENTS.

Description of Event or Problem · 1

IT WAS REPORTED CUP ANGLE VALUES WERE OPPOSITE/DIFFERENT THAN WHAT WAS EXPECTED. WENT THROUGH CHECKLIST OF POTENTIAL REASONS, AND ALL WAS DONE CORRECTLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
801132	ORTHALIGN PLUS SYSTEM	REFERENCE SENSOR 5	OLO	ORTHALIGN, INC.	403087		00810832030072

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization