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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 209999
Device Problems Computer Software Problem (1112); Output Problem (3005)
Patient Problem Discomfort (2330)
Event Date 03/27/2019
Event Type  Injury  
Manufacturer Narrative
¿as part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical. A supplemental report will be submitted when additional information becomes available. ¿.
 
Event Description
This pi is for the robot. Patient called stating he had a right knee replacement done on (b)(6) 2018 and was revised on (b)(6) 2019 due to instability. Patient stated his surgery was done robotically, and would like to know if the robot was involved in a recall.
 
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Brand Name3.0 RIO® ROBOTIC ARM - MICS
Type of DeviceSTEREOTAXIC DEVICE, ROBOTICS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer (Section G)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer Contact
bethany hinson
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key8573854
MDR Text Key143841531
Report Number3005985723-2019-00334
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number209999
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/02/2019 Patient Sequence Number: 1
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