MAUDE Adverse Event Report: MAKO Surgical Corp. MAKO ROBOTIC ARM 3.1; Orthopedic Stereotaxic Instrument

Catalog Number	219999
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Paresis (1998); Loss of Range of Motion (2032)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The surgery was conducted on (b)(6) 2026.After surgery, the patient is unable to dorsiflex the ankle and is peroneal nerve palsy.The physician commented that he suspect that the sciatic nerve, which is connected to the peroneal nerve, may have been compressed during the surgery.

• 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: deepan raju srinivasan ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 24869911
• Report Number: 3005985723-2026-00175
• Device Sequence Number: 18649104
• Product Code: OLO
• UDI-Device Identifier: 07613327395280
• UDI-Public: 07613327395280
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 219999
• Was Device Available for Evaluation?: No
• 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: 03/19/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown