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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
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MAKO SURGICAL CORP. RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/13/2014
Event Type  Injury  
Event Description
The surgeon performed a partial knee arthroplasty procedure on (b)(6) 2014 using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee (mck) implants.The surgeon stated to a makoplasty specialist that during the surgery the tips of the bone pins "sheared off" during insertion of the pins.The broken tips of the bone pins remained embedded in the pt's tibia post operatively.
 
Manufacturer Narrative
As part of normal complaint follow up, an eval of the event was completed at mako surgical.A supplemental report will be filed when additional info is obtained.
 
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Brand Name
RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
Manufacturer (Section D)
MAKO SURGICAL CORP.
ft. lauderdale FL
Manufacturer Contact
william tapia
2555 davie rd.
ft. lauderdale, FL 33317
9546280605
MDR Report Key4381181
MDR Text Key5121318
Report Number3005985723-2014-00209
Device Sequence Number1
Product Code KRR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112507
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 11/26/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/26/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO)
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