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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL, CHECKPOINT, STERILE STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. TIBIAL, CHECKPOINT, STERILE STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 111651
Device Problems No Apparent Adverse Event (3189); Non Reproducible Results (4029)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/13/2019
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
During a mako tka case that my colleague (b)(6) and i were running together, after all cuts were done and implants were cemented, the scrub nurse noticed that the tibial checkpoint was missing from the patient¿s tibia. Since the checkpoint could not be found anywhere, the surgeon requested an x-ray of the patient before closing the wound. At this stage, the checkpoint was found underneath the implanted tibial component, which at that point was already cemented on bone.
 
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Brand NameTIBIAL, CHECKPOINT, STERILE
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 Key8353291
MDR Text Key136604975
Report Number3005985723-2019-00159
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K112507
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 06/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number111651
Device Lot NumberN/A
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 Received05/30/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/20/2019 Patient Sequence Number: 1
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