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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
Catalog Number 210080
Device Problems Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)
Event Date 09/12/2019
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 proximal edge of the boot is fraying and spd is concerned that it may harbor microorganisms or harm the patient during a case. 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
bethany hinson
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key9079091
MDR Text Key158897866
Report Number3005985723-2019-00681
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 12/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number210080
Device Lot Number201743092901
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 Received11/14/2019
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: 09/17/2019 Patient Sequence Number: 1
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