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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL, CHECKPOINT, STERILE ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MAKO SURGICAL CORP. TIBIAL, CHECKPOINT, STERILE ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 111651
Device Problem Insufficient Information (3190)
Patient Problems Wound Dehiscence (1154); Foreign Body In Patient (2687)
Event Date 04/13/2020
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
The wound was closed while the tibial pin remained in the femur. I noticed by x-ray photography. Immediately after that, at the time of the operation on the opposite side, it was removed. Update: why was a tibial pin used in the patient¿s femur? please clarify or provide corrections as needed: the tibial pin was not used on the femur, it was left on the femur. Did the patient¿s wound have to be re-opened to remove the tibial pin? immediately after that, there was surgery on the other side, so they removed it. At what point was the x-ray taken when the pin was noticed still in the femur? after closing the wound. Did the patient come out of anesthesia between the side with the tibial pin remaining in the femur, and the start of the operation on the opposite site? unk. What side of the patient was the original side (the side with the reported tibial pin)?left please estimate any surgical delay, even if under a minute: unk. Were all pieces removed? yes, but the method is unknown.
 
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Brand NameTIBIAL, CHECKPOINT, STERILE
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 Key10038186
MDR Text Key190319232
Report Number3005985723-2020-00198
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
PMA/PMN Number
K112507
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 05/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number111651
Device Catalogue Number111651
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 Received05/18/2020
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: 05/08/2020 Patient Sequence Number: 1
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