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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 Problem Insufficient Information (3190)
Patient Problem Discomfort (2330)
Event Date 09/19/2013
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
The surgeon completed a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system. Tibial loosening with mechanical failure, left uka. Revision of tibial compartment.
 
Manufacturer Narrative
Reported event: an event regarding a pka revision involving a 3. 0 rio robotic arm - mics, catalog: 209999 was reported. Method and results: device history review: not performed as the device being inspected is software. Rio serial number not reported. Complaint history: based on the device identification (pn 209999) the complaint databases were reviewed from 2011 to present for similar reported events regarding patient revision from pka to tka. There were eight other reported events for the listed catalog number. (b)(4). Conclusion: device inspection could not be performed as no session data was available. Per the mps, "robot (b)(4) was upgraded to accommodate the tka software application on (b)(6) 2016 and needed a new hard drive. The old hard drive is still at the hospital but not plugged into the machine and i have no way to access any information on it. Robot (b)(4) was removed from the hospital altogether and a different robot replaced it (b)(4) to accommodate a hardware upgrade that was required to run the robotic tka software. ¿ the device was not returned to the manufacturer.
 
Event Description
The surgeon completed a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system. Tibial loosening with mechanical failure, left uka. Revision of tibial compartment.
 
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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
michael mcavenia
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key6424867
MDR Text Key70579848
Report Number3005985723-2017-00136
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112507
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2017
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 Received04/28/2017
Was Device Evaluated by Manufacturer? No
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: 03/22/2017 Patient Sequence Number: 1
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