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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. 2.7 DEGREE ANGLED SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. 2.7 DEGREE ANGLED SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 212480
Device Problems Mechanical Problem (1384); Premature Separation (4045)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/15/2019
Event Type  malfunction  
Manufacturer Narrative
As part of the 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
While making the femur distal cut, the sawblade would not stay locked into the mics angled attachment. Attempted to retighted the attachment in order to complete the cut but the issue was not resolved. Had to use a different attachment in order to complete the case. Case type: tka: surgical delay: 10 minutes. Update: did the saw attachment become detached during cutting? -- yes, the blade came off during cutting.
 
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Brand Name2.7 DEGREE ANGLED SAGITAL SAW
Type of DeviceSTEREOTAXIC DEVICE, ROBOTICS
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
bethany hinson
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key8814533
MDR Text Key152057045
Report Number3005985723-2019-00525
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143752
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number212480
Device Lot Number3501935 / 35010817
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/31/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/22/2019 Patient Sequence Number: 1
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