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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
Catalog Number 209999
Device Problems Computer Software Problem (1112); Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/08/2019
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
Mako tha software measured cup anteversion at 24 degrees.Post-op x-rays measure 9 degrees of anteversion.Dr.(b)(6) expressed concern regarding the discrepancy and would like someone to review the case and x-rays.Case type: tha.
 
Manufacturer Narrative
"reported event: an event regarding incorrect landmark selected involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: a review of the dhr associated with rio 482 found quality inspection procedures successfully passed.Complaint history: a search of the complaint database under device identification pn 209999 reports similar complaints for tha software - incorrect landmark selected.The complaint record numbers are: (b)(4).Conclusion: a review of this case had several findings.Bone registration had an rms error of.54 mm in addition to this there was a large discrepancy between the anterior ct landmark and anterior patient landmark.This can lead to an undesirable rotation in the transform.I was able to confirm that there was red visual present on the inferior edge of the acetabulum.I was "able" to confirm that the application showed a cup version of 23 and inclination of 37 but was unable to confirm the stated version based on x-rays as x-rays were not provided.".
 
Event Description
Mako tha software measured cup anteversion at 24 degrees.Post-op x-rays measure 9 degrees of anteversion.Dr.(b)(6) expressed concern regarding the discrepancy and would like someone to review the case and x-rays.Case type: tha.
 
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Brand Name
3.0 RIO® ROBOTIC ARM - MICS
Type of Device
STEREOTAXIC DEVICE, ROBOTICS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key8795643
MDR Text Key151204600
Report Number3005985723-2019-00517
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00848486030407
UDI-Public00848486030407
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 11/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number209999
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/08/2019
Initial Date FDA Received07/16/2019
Supplement Dates Manufacturer Received10/23/2019
Supplement Dates FDA Received11/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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