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U.S. Department of Health and Human Services

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

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MAKO SURGICAL CORP. BAR EXTENSION STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Model Number 210070
Device Problems Material Frayed (1262); Material Integrity Problem (2978)
Patient Problem Tissue Damage (2104)
Event Date 09/26/2019
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
Splintering in the black leg holder has occurred and gave employee in cpd splinters (carbon fiber) that has caused concern as to the structural integrity of the device and if further splintering could occur in the or and affect the patient. Would like all carbon pieces replaced (creating individual complaints per piece). Case type: (b)(4). Patient was under anesthesia.
 
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Brand NameBAR EXTENSION
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 Key9141691
MDR Text Key161063478
Report Number3005985723-2019-00709
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
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 Received10/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number210070
Device Catalogue Number210070
Device Lot Number608499
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/10/2019
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? 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: 10/01/2019 Patient Sequence Number: 1
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