MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO ROBOTIC ARM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number MAKO

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2023

Event Type  malfunction  

Event Description

Patient in for surgery and robot surgeries cancelled due to malfunction before surgery.

• Brand Name: MAKO ROBOTIC ARM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• MDR Report Key: 16435093
• MDR Text Key: 310166633
• Report Number: 16435093
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MAKO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2023
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1