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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER IRELAND LTD., INSTRUMENTS DIVISION STRYKER MAKO ORTHOPEDICS ROBOTIC-ARM ASSISTED SURGERY ORTHOPEDIC STEREOTAXIC INSTRUMENT

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STRYKER IRELAND LTD., INSTRUMENTS DIVISION STRYKER MAKO ORTHOPEDICS ROBOTIC-ARM ASSISTED SURGERY ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number MAKO
Device Problems Positioning Problem (3009); Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/14/2020
Event Type  Injury  
Event Description
Mako robotic equipment made incorrect posterior chamber cut during surgery. Fda safety report id# (b)(4).
 
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Brand NameSTRYKER MAKO ORTHOPEDICS ROBOTIC-ARM ASSISTED SURGERY
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER IRELAND LTD., INSTRUMENTS DIVISION
kalamazoo MI 49002
MDR Report Key9616158
MDR Text Key176076692
Report NumberMW5092377
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 01/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMAKO
Device Catalogue Number207110
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/21/2020 Patient Sequence Number: 1
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