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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. 2.1 RIO ROBOTIC ARM INT. ORTH. SYSTEM; STEREOTACTIC DEVICE
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MAKO SURGICAL CORP. 2.1 RIO ROBOTIC ARM INT. ORTH. SYSTEM; STEREOTACTIC DEVICE Back to Search Results
Catalog Number 204000
Device Problems Difficult To Position (1467); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 06/23/2015
Event Type  Injury  
Event Description
The surgeon performed a makoplasty total hip arthroplasty using the robotic arm interactive orthopedic system (rio).The robotic arm angle for correct implant placement could not be achieved.The case was successfully completed using manual instruments.
 
Manufacturer Narrative
As part of normal complaint follow-up, an evaluation of the event is being completed at mako surgical.A supplemental report will be filed when additional information is obtained.
 
Manufacturer Narrative
Reported event: an event regarding excessive burred area, involving a 2.1 rio robotic arm int.Orth.System, catalog: 204000 was reported.Method and results: device history review: a review of the dhr associated with rio 319 found quality inspection procedures successfully passed.Complaint history: based on the device identification (pn 204000) the complaint databases were reviewed from 2011 to present for similar reported events regarding inaccurate arm angle.There were no other reported events for the listed catalog number.Conclusion: device inspection could not be performed, no session data was provided.Four communications were made.Device was not returned for evaluation.
 
Event Description
The surgeon performed a makoplasty total hip arthroplasty using the robotic arm interactive orthopedic system (rio).The robotic arm angle for correct implant placement could not be achieved.The case was successfully completed using manual instruments.
 
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Brand Name
2.1 RIO ROBOTIC ARM INT. ORTH. SYSTEM
Type of Device
STEREOTACTIC DEVICE
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
jonathan reeves
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key4903155
MDR Text Key6068672
Report Number3005985723-2015-00121
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121064
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number204000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/23/2015
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
Patient Weight52
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