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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN 111653 FEMORAL CHECKPOINT STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. UNKNOWN 111653 FEMORAL CHECKPOINT STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number UNK_OFL
Device Problems Difficult to Remove (1528); Appropriate Term/Code Not Available (3191)
Patient Problems Injury (2348); Foreign Body In Patient (2687)
Event Date 12/18/2019
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
Tha surgery was performed using mako. Prior to pelvic registration, impact driver was used to place a pelvic checkpoint screw on the illiac above the acetabulum. As a result, screw penetrated the bone and embedded on the extra-abdominal pelvis. For a while, surgeon tried to remove the screw using inoperative images, but it was difficult to remove with that approach. Surgeon decided to continue procedure without removing the screw. Will perform a ct scan and determine whether to remove the screw.
 
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Brand NameUNKNOWN 111653 FEMORAL CHECKPOINT
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 Key9594226
MDR Text Key175447607
Report Number3005985723-2020-00035
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_OFL
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 Received03/27/2020
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 Initial

Patient Treatment Data
Date Received: 01/15/2020 Patient Sequence Number: 1
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