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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN_JOINT REPLACEMENT_PRODUCT ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MAKO SURGICAL CORP. UNKNOWN_JOINT REPLACEMENT_PRODUCT ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 219999
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bone Fracture(s) (1870)
Event Date 01/22/2021
Event Type  Injury  
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
During mako tka, the surgeon noticed a crack on the tibia after cutting it, but he continued procedure, then a fracture occurred at ap face when keel was punched. It was fixed by using soft wire, fixed the keel by chisel and implanted and closing the incision. The surgeon wanted to know the root casue of the event, whether it was becase mako procedure, aggressive use of kocher to pull the bone or forced pulling tibia to avoid medial exfoliation.
 
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Brand NameUNKNOWN_JOINT REPLACEMENT_PRODUCT
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
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 Key11340601
MDR Text Key232338074
Report Number3005985723-2021-00024
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number219999
Device Catalogue NumberUNK_JR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/07/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/17/2021 Patient Sequence Number: 1
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