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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 ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 209999
Device Problem Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Injury (2348)
Event Date 05/17/2019
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. Device not returned.
 
Event Description
This pi is for the robot used in the primary procedure patient had a right mako tha surgery on (b)(6) 2019. She started to experience drainage from incision approx. (b)(6) 2019. The incision opened on (b)(6) 2019, patient went to the er and was admitted. Patient was partially revised on (b)(6) 2019. Patient was discharged a week after revision and was given antibiotics. On (b)(6) 2019 patient went for a follow-up visit and was told to follow up with her original surgeon. Patient went to see the original surgeon the same day and was admitted to the hospital. During her hospital stay, multiple i&ds were performed approx. (b)(6) 2019. Patient was discharged on (b)(6) 2019. Patient continued to experience drainage after being discharged. All components were revised on (b)(6) 2019 and a cement spacer was placed. Another i&d was performed on (b)(6) 2019 and was placed in rehab. On (b)(6) 2019 the spacer was removed, and patient was implanted with competitor product.
 
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Brand Name3.0 RIO® ROBOTIC ARM - MICS
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
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
daniela davila
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key9607703
MDR Text Key180582522
Report Number3005985723-2020-00051
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 06/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number209999
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 Received05/27/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/20/2020 Patient Sequence Number: 1
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