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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. BONE PIN, 4MM X 110MM, STERILE 2 PACK STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. BONE PIN, 4MM X 110MM, STERILE 2 PACK STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Model Number 144110
Device Problem Fracture (1260)
Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Event Date 11/13/2019
Event Type  malfunction  
Manufacturer Narrative
As part of the 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 surgeon began to manually ream the tibia for a universal baseplate with pressfit stem, when removing the tibial bone pins for the array assembly one of the bone pins broke inside the patient. Using x-ray the surgeon was able to locate the bone pin fixed inside cortical bone and was unable to retrieve it. Case type: tka. Surgical delay: 15 minutes.
 
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Brand NameBONE PIN, 4MM X 110MM, STERILE 2 PACK
Type of DeviceSTEREOTAXIC DEVICE, ROBOTICS
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 Key9453219
MDR Text Key185292611
Report Number3005985723-2019-00901
Device Sequence Number1
Product Code OLO
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 company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number144110
Device Catalogue Number144110
Device Lot NumberW64539-1
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 Received01/27/2020
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: 12/11/2019 Patient Sequence Number: 1
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