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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN_JOINT REPLACEMENT_ROBOTICS_PRODUCT STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. UNKNOWN_JOINT REPLACEMENT_ROBOTICS_PRODUCT STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number UNK_OFL
Device Problems Use of Device Problem (1670); Insufficient Information (3190)
Patient Problem Bone Fracture(s) (1870)
Event Date 10/31/2017
Event Type  Injury  
Manufacturer Narrative
Follow-up #1 and final report submitted to update sections based on the results of investigation. It was reported that the doctor decided to a stryker navigation system with the mako system after being advised against doing so. Utilizing the stryker navigation system with the mako robot is an off-label use. The difference in alignment noticed during surgery is therefore due to user error. The data at this time shows that the rio operated as expected. No system defect or malfunction is suspected.
 
Event Description
Dr. (b)(6) utilized mako tka and stryker navigation during the same knee arthroplasty. Bone was registered with both systems and distal femur and proximal tibia cuts were made using mako. Knee was then balanced with both systems and remaining femur cuts were made with navigation. The decision to use a ps femur was made when balancing the knee. During trialing radiographs were obtained and it was realized the distal femur was fractured. Screws were used to reduce fracture and a ts femur with stem was used.
 
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
Dr. (b)(6) utilized mako tka and stryker navigation during the same knee arthroplasty. Bone was registered with both systems and distal femur and proximal tibia cuts were made using mako. Knee was then balanced with both systems and remaining femur cuts were made with navigation. The decision to use a ps femur was made when balancing the knee. During trialing radiographs were obtained and it was realized the distal femur was fractured. Screws were used to reduce fracture and a ts femur with stem was used.
 
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Brand NameUNKNOWN_JOINT REPLACEMENT_ROBOTICS_PRODUCT
Type of DeviceSTEREOTAXIC DEVICE, ROBOTICS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key7017576
MDR Text Key280464093
Report Number3005985723-2017-00542
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
PMA/PMN Number
K170581
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_OFL
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2017
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/10/2017 Patient Sequence Number: 1
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