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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 Resultor Readings (1535); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/19/2021
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
Mps reported inaccurate cuts and rio registration issues. Mps was having difficulty passing sawblade checkpoint, re-registering robot, and green not going away during bone prep. Mps had to shutdown twice to be able to pass rio registration. Mps confirmed no arrays were bumped. This has occurred on multiple cases. Requested logs. Already spoke with fse.
 
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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 Key11995143
MDR Text Key256770427
Report Number3005985723-2021-00104
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141989
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 08/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number209999
Device Catalogue Number209999
Device Lot NumberROB481
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 Received07/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/10/2016
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: 06/14/2021 Patient Sequence Number: 1
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