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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 209999
Device Problem Insufficient Information (3190)
Patient Problems Bone Fracture(s) (1870); No Known Impact Or Consequence To Patient (2692)
Event Date 10/17/2017
Event Type  Injury  
Manufacturer Narrative
Reported event: an event regarding a crack/fracture involving a 3. 0 rio robotic arm - mics, catalog: 209999 was reported. Method & results: -device history review: a review of the dhr associated with rio 212 found quality inspection procedures successfully passed. -complaint history: based on the device identification (pn 209999) the complaint databases were reviewed from 2011 to present for similar reported events regarding crack/fracture. There was only 2 other reported event ((b)(4)). Conclusion: a case investigation was unable to be performed as the session file was not received. Sessions were not provided.
 
Event Description
The patient experienced a post op spiral fracture along the femoral shaft. External superior condylar shaft region to mid diaphysis. Her mako tka surgery was conducted on sept. 27th with no adverse events. Pre-op scans showed valgus deformity. Intra-op the medial co-lat ligaments still showed looseness even after valgus implant placement. Valgus implant placement was maxed out but within recommended values and lateral release was conducted to better balance the knee. A ts insert was used for max constraint with a cemented ps femur and universal baseplate. Fracture did not occur in surgery. Fracture occurred on oct. 17 when patient was walking to the bathroom.
 
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
The patient experienced a post op spiral fracture along the femoral shaft. External superior condylar shaft region to mid diaphysis. Her mako tka surgery was conducted on (b)(6) with no adverse events. Pre-op scans showed valgus deformity. Intra-op the medial co-lat ligaments still showed looseness even after valgus implant placement. Valgus implant placement was maxed out but within recommended values and lateral release was conducted to better balance the knee. A ts insert was used for max constraint with a cemented ps femur and universal baseplate. Fracture did not occur in surgery. Fracture occurred on (b)(6) when patient was walking to the bathroom.
 
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Brand Name3.0 RIO® ROBOTIC ARM - MICS
Type of DeviceSTEREOTAXIC DEVICE, ROBOTICS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key6980892
MDR Text Key281980040
Report Number3005985723-2017-00518
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 01/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number209999
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2017
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/26/2017 Patient Sequence Number: 1
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