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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. CORTICAL SCREW, STERILE STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. CORTICAL SCREW, STERILE STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 116240
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Bone Fracture(s) (1870); Pain (1994)
Event Date 08/23/2017
Event Type  Injury  
Manufacturer Narrative
Follow-up #1 and final report submitted to update sections based on the results of investigation. Patient admitted back into hospital 1 week post mako hip procedure for pain. X-ray showed a fracture at the greater trochanter around mako cortical screw site. Device evaluation and results: not performed as the device was not returned for evaluation. Device history review: not performed as the lot number was not provided. Complaint history review: not performed as the lot number was not provided. The failure mode could not be confirmed because the part was not available for evaluation. If device and/or additional information become available, this investigation will be reopened. No action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard. The device was not returned for evaluation.
 
Event Description
Patient admitted back into hospital 1 week post mako hip procedure for pain. X-ray showed a fracture at the greater trochanter around mako cortical screw site.
 
Manufacturer Narrative
As part of 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
Patient admitted back into hospital 1 week post mako hip procedure for pain. X-ray showed a fracture at the greater trochanter around mako cortical screw site.
 
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Brand NameCORTICAL SCREW, 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 Key6823560
MDR Text Key250185132
Report Number3005985723-2017-00400
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K170593
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 11/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number116240
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 Received10/30/2017
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: 08/28/2017 Patient Sequence Number: 1
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