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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
Catalog Number 209063
Device Problems Difficult to Remove (1528); Non Reproducible Results (4029)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/18/2018
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
Saw attachment sticking in mics handpiece. Very large force required to remove. Once removed oil visible 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
bethany hinson
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key8205124
MDR Text Key131709001
Report Number3005985723-2018-00800
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K142530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number209063
Device Lot NumberLOT - 4203265
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/25/2019
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: 12/28/2018 Patient Sequence Number: 1
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