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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Model Number 209063
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/02/2022
Event Type  malfunction  
Manufacturer Narrative
As part of 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
After making distal cut, cut was showing red but measuring. 8 proud with planar probe. Checked to make sure sawblade and attachment were tightened and tried again. Reregistered mics and tried again. No more bone was taken. Replaced mics and retried distal cut and 1 mm more bone was taken. Case type / application: tka.
 
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Brand NameHANDPIECE MICS
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
juana hiciano
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key14748573
MDR Text Key298718256
Report Number3005985723-2022-00078
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number209063
Device Catalogue Number209063
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received06/02/2022
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 Treatment Data
Date Received: 06/20/2022 Patient Sequence Number: 1
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