MAUDE Adverse Event Report: ORTHALIGN INC. LANTERN "ORTHALIGN"; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Lot Number 2303071LS

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Event description: the touch screen of the lantern "orthalign" quit working.Complaint number: (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LANTERN "ORTHALIGN"
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ORTHALIGN INC.
• MDR Report Key: 17488288
• MDR Text Key: 320679832
• Report Number: MW5120986
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Lot Number: 2303071LS
• Patient Sequence Number: 1