MAUDE Adverse Event Report: ORTHOGRID SYSTEMS, INC. PHANTOMMSK HIP; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Model Number /PHANTOM MSK

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2020

Event Type  malfunction  

Event Description

System failure.Test did not happen.Fda safety report id # (b)(4).

• Brand Name: PHANTOMMSK HIP
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): ORTHOGRID SYSTEMS, INC.
• MDR Report Key: 9733315
• MDR Text Key: 180632251
• Report Number: MW5093112
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: /PHANTOM MSK
• Device Lot Number: 2.4.0
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 27