MAUDE Adverse Event Report: ORTHOFIX; SOFTWARE FOR DIAGNOSIS/TREATMENT

Device Problem Communication or Transmission Problem (2896)

Patient Problem Insufficient Information (4580)

Event Date 02/24/2021

Event Type  malfunction  

Event Description

Device not recording usage properly.Fda safety report id# (b)(4).

• Brand Name: ORTHOFIX
• Type of Device: SOFTWARE FOR DIAGNOSIS/TREATMENT
• MDR Report Key: 11398751
• MDR Text Key: 234634446
• Report Number: MW5099722
• Device Sequence Number: 1
• Product Code: OSN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1