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U.S. Department of Health and Human Services

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

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MAKO SURGICAL CORP. BOOT ASSEMBLY STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Model Number 210080
Device Problems Degraded (1153); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/19/2019
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
The carbon fiber portion of the leg holder is starting to chip and stick out and is very sharp. Case type: tka.
 
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Brand NameBOOT 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
collin neitzel
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9119791
MDR Text Key160156485
Report Number3005985723-2019-00697
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
Report Date 01/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number210080
Device Catalogue Number210080
Device Lot Number201843012201 / 20174306080
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/30/2019
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: 09/25/2019 Patient Sequence Number: 1
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