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

Device Problem No Display/Image (1183)

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

Event Date 12/05/2022

Event Type  malfunction  

Event Description

Stryker mako system would not display on screen.Doctor chose to proceed without.Case continued without incident.Stryker mako vendor repaired screen connection after case was completed.

• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 16282897
• MDR Text Key: 308641067
• Report Number: 16282897
• 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: 01/18/2023

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
• 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: 01/18/2023
• Date Report to Manufacturer: 02/02/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA