MAUDE Adverse Event Report: MAKO Surgical Corp. MAKO ROBOTIC ARM 3.1; orthopedic stereotaxic instrument

Catalog Number	219999
Medical Device Problem Codes	Application Program Problem: Parameter Calculation Error (1449); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was provided: mps reported communication errors and application showing cup in incorrect hip.Mps confirmed registration/ct landmarks/op-side of acetabulum, cleaned cables, and re-entered application.Wo: cleaned fibers cleaned camera lens ,preformed pm tests and checks, automatic kinematic calibrated right side of rio.Rio passed all required testing, rio is cleared for clinical use.

• Brand Name: MAKO ROBOTIC ARM 3.1
• Common Device Name: orthopedic stereotaxic instrument
• Manufacturer (Section D): MAKO Surgical Corp.; 3365 enterprise ave; weston FL 33331
• Manufacturer (Section G): MAKO Surgical Corp.; 3365 enterprise ave; weston FL 33331
• Manufacturer Contact: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 25234399
• Report Number: 3005985723-2026-00247
• Device Sequence Number: 10289758
• Product Code: OLO
• UDI-Device Identifier: 07613327395280
• UDI-Public: 07613327395280
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 219999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2026
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 05/20/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown