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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 Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/24/2021
Event Type  malfunction  
Manufacturer Narrative
As part of 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
Measured distal cuts with the green probe which were 2. 4 deep on the lateral side, and 3. 2 deep on the medial. With the planar probe we were shown to be 1. 4 deep, with 3 degrees varus and 3 degrees flexed on the lat side. With the planar probe on the med side we were 2. 1 deep, 3. 0 varus and 2. 7 degrees flexed. Bone prep screen showed no red on the distal cut, excluding osteophytes. Bone registration was. 3 for the femur. Probe registration was. 9 for the blue and. 3 for the green. Robot registration was at. 27. When measured with a caliper, lateral condyle that was removed, measured 6mm. Planned resection on the lat side was 1. 5 mm. On top of this, we were 2. 4 deep according to the green probe, and so out total should have been 3. 9 mm. Case completed manually. No surgical delay. Case type / application: tka.
 
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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
marisol santiago
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12495391
MDR Text Key272188610
Report Number3005985723-2021-00159
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00848486030407
UDI-Public00848486030407
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142530
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 12/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number209999
Device Catalogue Number209999
Device Lot NumberROB100
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/12/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/28/2010
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: 09/20/2021 Patient Sequence Number: 1
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