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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. BASE BAR ASSEMBLY STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. BASE BAR ASSEMBLY STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 210060
Device Problem Material Integrity Problem (2978)
Patient Problems Discomfort (2330); No Known Impact Or Consequence To Patient (2692)
Event Date 05/04/2017
Event Type  malfunction  
Manufacturer Narrative
Reported event: customer reported that the carbon fiber is splintering and pitting. Device evaluation and results: device evaluation was performed and the base bar assembly event was confirmed. Device history review: review of the device history records indicate 40 devices were manufactured and inspected on 11-15-2016 and were accepted with no reported discrepancies. Complaint history review: based on the device identification, the catsweb and trackwise complaint databases were reviewed from 2011 to present for similar reported events regarding the base bar assembly. There has been one other event for the referenced lot number. Pr # 1518583 - was found to be from the same lot as the part in this complaint. The part from pr # 1518583 displayed a similar failure. Conclusions: the base bar assembly shows minor signs of wear. Very small chips on the bar can be observed. Corrective action/preventive action: as the event did not involve a manufacturing related product problem indicating a non-conformity, adverse trend, or unanticipated hazard, no corrective action is required at this time.
 
Event Description
Carbon fiber is splintering and pitting.
 
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
Carbon fiber is splintering and pitting.
 
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Brand NameBASE BAR ASSEMBLY
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 Key6552662
MDR Text Key208293850
Report Number3005985723-2017-00204
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,Followup
Report Date 04/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number210060
Device Lot Number570101
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 Received04/13/2020
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: 05/08/2017 Patient Sequence Number: 1
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