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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. BONE PIN, 3.2MM X 140MM, STERILE 2 PACK STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. BONE PIN, 3.2MM X 140MM, STERILE 2 PACK STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 143140
Device Problems Use of Device Problem (1670); Non Reproducible Results (4029)
Patient Problem Bone Fracture(s) (1870)
Event Date 01/23/2019
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
Patient experienced fracture at femoral pin site post op. The pin was removed and discarded after the case. A few weeks after the case, the patient¿s femur fractured where the pin was. The pin is not available for return because it was discarded after the case. Case type: tka.
 
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Brand NameBONE PIN, 3.2MM X 140MM, 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
bethany hinson
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key8306999
MDR Text Key135061900
Report Number3005985723-2019-00097
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 11/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number143140
Device Lot NumberW51426-2
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 Received10/30/2019
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: 02/05/2019 Patient Sequence Number: 1
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