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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MAKO SURGICAL CORP. ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Device Problems Loose or Intermittent Connection (1371); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/22/2021
Event Type  malfunction  
Event Description
Surgeon started a right knee mako robotic-assisted total knee arthroplasty without problems until the surgeon had to saw off parts of the knee to prep for trial parts the robotic arm saw device started to wiggle with the screw on handpiece becoming loose. The screw and handpiece were retrieved outside of the field and no parts got into the operative wound.
 
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Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key12623186
MDR Text Key276152648
Report Number12623186
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/30/2021
Event Location Hospital
Date Report to Manufacturer10/13/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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