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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 Material Frayed (1262); Sharp Edges (4013)
Patient Problems Tissue Damage (2104); No Patient Involvement (2645)
Event Date 01/22/2020
Event Type  malfunction  
Manufacturer Narrative
As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical. A supplement al report will be submitted when additional information becomes available.
 
Event Description
Was asked back to spd to grab the bar extension and the boot (both carbon fiber pieces) from the clean side of spd because a hospital associate was checking both items for cleanliness and got splinters from the boot and extension. The boot is visibly frayed at the distal end and the bar extension, the associate told me she got them also from the distal end. Spd manager has asked me to replace both of these so that future spd staff do not get injured due to splintering. Zero issues before, during, or immediately after a case so i am not treating this as a case issue. Case type: n/a spd staff got carbon fiber splinters. Was reported in their own facility. Spd manager asked that i simply get them replaced, the injury is very minor and has been addressed internally. No pictures taken of the damage to these pieces.
 
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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
daniela davila
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key9696039
MDR Text Key180783646
Report Number3005985723-2020-00084
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 04/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number210080
Device Catalogue Number210080
Device Lot Number201643120901
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/07/2020
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: 02/11/2020 Patient Sequence Number: 1
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