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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEMORAL/TIBIAL CHECKPOINT KIT -(STERILE) STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. FEMORAL/TIBIAL CHECKPOINT KIT -(STERILE) STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Model Number 111645
Device Problems Fracture (1260); Insufficient Information (3190)
Patient Problem Tissue Damage (2104)
Event Date 11/05/2019
Event Type  Injury  
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
It was reported that after right mako knee implantation on (b)(6) 2019, post-op x-rays revealed the femoral checkpoint was in the patient. On (b)(6) 2019, patient underwent surgery to remove the checkpoint. The rep who reported the (b)(6) surgery was not present for either procedure, but two mps's were present for the (b)(6) procedure. Rep reported that no further information will be released by the hospital or surgeon.
 
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Brand NameFEMORAL/TIBIAL CHECKPOINT KIT -(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
daniela davila
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key9394852
MDR Text Key168599666
Report Number3005985723-2019-00865
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143752
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number111645
Device Catalogue Number111645
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2020
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: 12/02/2019 Patient Sequence Number: 1
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