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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 Incorrect, Inadequate or Imprecise Resultor Readings (1535); Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)
Patient Problems Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/16/2020
Event Type  Injury  
Manufacturer Narrative
As part of the 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
As reported: "as i recall, we started the case as the scrub tech was putting the leg holder on the bed she tightened it but it wasn't tight enough and it fell on the floor. We exchanged that leg holder for a competitor boot and re-prepped and re-draped the patient. We trialed and the doctor told me multiple times that it was loose in extension which was what was explained to him on the graph prior to bone prep. He said that the graph would not have made him so loose. I told him if he was concerned that we did not burr to plan we could check our checkpoints to ensure that our arrays and the cutter did not move. He the put his probe in the femoral checkpoint with one hand then went to ensure the array was tight with the other. The array could have been tighter and with some force he was able to move it after jiggling it around a bit but during the case i didn't see from its original location. Surgeon: during trialing the patient was loose in flexion with a 10mm poly. I built up a cement mantle to place the femur on. Post-op rom 5-80 degrees at present. Entirely due to component position. This patient will need a manipulation. Update: as per response, patient will have manipulation under anesthesia.
 
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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
alessandra chavez
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key9837669
MDR Text Key183772408
Report Number3005985723-2020-00161
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 company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number209999
Device Lot NumberUNKNOWN
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 Received11/09/2020
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: 03/16/2020 Patient Sequence Number: 1
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