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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
Model Number 209999
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Output Problem (3005)
Patient Problems Tissue Damage (2104); Injury (2348)
Event Date 08/14/2019
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.
 
Event Description
Case was proceeding as normal. Robot operating as normal. Surgeon trialed and was happy with results. Arrays and pins were taken off of the patient. Surgeon chose to cement. 4 femur, 4 tibia, 9 poly insert. Cement was applied to implants and implants were put on patient, including cs poly. Surgeon cleaned up cement around implants using various tools. Surgeon let down the turnicate and pulled leg into extension and a pool of blood formed. This is when it was noticed that an artery was nicked. Polyethylene insert was taken out. Bleeding stopped when leg was in flexion, but continues when pulled into extension. Doppler used to check pulse on ankle. Call made to a vascular surgeon to come in and assess. Awaiting outcome. Case type: tka. Surgical delay: 30-60 minutes.
 
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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
daniela davila
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key8928825
MDR Text Key155497518
Report Number3005985723-2019-00600
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 04/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number209999
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 Received03/28/2020
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: 08/25/2019 Patient Sequence Number: 1
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