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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM; STEREOTAXIC DEVICE
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MAKO SURGICAL ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM; STEREOTAXIC DEVICE Back to Search Results
Model Number 204000
Device Problems Device Displays Incorrect Message (2591); Power Problem (3010)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/30/2014
Event Type  malfunction  
Event Description
The surgeon was performing a makoplasty partial knee arthroplasty using the robotic arm interactive orthopedic system (rio) and the restoris multicompartmental knee (mck) implant system.Prior to burring, the rio powered down without notice (did not beep)- it was verified that no cords or connections were loose and no shutdown command was given.The rio was powered up and homing was performed.The case info was saved, checkpoints were confirmed, and the case was continued.There were no further power issues and the case was completed successfully.
 
Manufacturer Narrative
As part of normal complaint f/u, an eval of the event has been initiated at mako surgical.A supplemental report will be filed when add'l info is obtained.
 
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Brand Name
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM
Type of Device
STEREOTAXIC DEVICE
Manufacturer (Section D)
MAKO SURGICAL
ft. lauderdale FL
Manufacturer Contact
william tapia
2555 davie rd.
ft. lauderdale, FL 33317
9546280605
MDR Report Key4254167
MDR Text Key17276488
Report Number3005985723-2014-00184
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 Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 09/30/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number204000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/30/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
SYSTEM; RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANT
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