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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. MOTOR ASSY, J3 STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. MOTOR ASSY, J3 STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 207569
Device Problems Mechanical Problem (1384); Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/13/2019
Event Type  malfunction  
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 number: (b)(4), rob542 - mps (b)(6) reported error 24 and could not pass homing on m3. Case type: tka. Surgery was not completed robotically. Update: "yes, patient was involved. During approach mode, while aligning itself for the femur distal cut the saw blade made contact with the patient¿s distal femur. Surgeon noted that blade did make a mark on the patient¿s bone, however they did not consider it arm and that section of bone was removed during manual tka. Surgeon had already made his exposure and no cuts had been made with the robot, so when the robot failed a standard instrumented tka was preformed. " approximately 20 min delay.
 
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Brand NameMOTOR ASSY, J3
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
bethany hinson
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key8946572
MDR Text Key156172450
Report Number3005985723-2019-00610
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 10/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number207569
Device Lot NumberNOT REPORTED
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2019
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: 08/29/2019 Patient Sequence Number: 1
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