Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM; STEREOTAXIC DEVICE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAKO SURGICAL ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM; STEREOTAXIC DEVICE Back to Search Results
Device Problems Electrical /Electronic Property Problem (1198); Device Inoperable (1663); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/22/2014
Event Type  malfunction  
Event Description
During set-up (pre-surgery checks) for a makoplasty total hip arthroplasty using the robotic arm interactive orthopedic system (rio), the makoplasty specialist was unable to release the emergency stop and thus could not release the robotic arm.Further troubleshooting attempts were unsuccessful and the surgeon opted to use a different mfr's equipment.
 
Manufacturer Narrative
As part of normal complaint f/u, an eval of the event is being conducted at mako surgical.A supplemental report will be filed if add'l results are obtained.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM
Type of Device
STEREOTAXIC DEVICE
Manufacturer (Section D)
MAKO SURGICAL
ft. lauderdale FL
Manufacturer Contact
william tapia
2555 davie rd., suite 110
ft. lauderdale, FL 33317
9546280605
MDR Report Key4231796
MDR Text Key5067448
Report Number3005985723-2014-00167
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 Health Professional,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 09/22/2014
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
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/22/2014
Initial Date FDA Received10/15/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-