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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 Intermittent Loss of Power (4016)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/05/2019
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
Mics will not pass angled saw attachment check point. We changed attachments and blade with no result. Change mics, check point passed. Case type: tka. Surgical delay: 16-30 minutes.
 
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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
collin neitzel
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9396705
MDR Text Key177394219
Report Number3005985723-2019-00868
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,Followup
Report Date 02/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number209063
Device Catalogue Number209063
Device Lot Number42020419 / 4206402
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2020
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: 12/02/2019 Patient Sequence Number: 1
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