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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO ROBOTIC ARM 3.1 ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MAKO SURGICAL CORP. MAKO ROBOTIC ARM 3.1 ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 219999
Device Problems Positioning Failure (1158); Incorrect, Inadequate or Imprecise Resultor Readings (1535); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bone Fracture(s) (1870)
Event Date 06/02/2021
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 a mako hip case, manual reaming was enabled. The medial distance remaining number showed we still had over 3mm to go, however the surgeon went through the medial wall. Additionally, the 3d bone model showed that we went through the medial wall, while the medial distance to ream number was still over 3mm. No surgical delay. Case type / application: ltha. Update 03/june/2021 wg: as per mps response, surgeon addressed the issue by manually inferiorizing the cup. Surgical delay 10 minutes.
 
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Brand NameMAKO ROBOTIC ARM 3.1
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
marisol santiago
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12078899
MDR Text Key258897646
Report Number3005985723-2021-00113
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K193515
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 05/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number219999
Device Catalogue Number219999
Device Lot NumberROB943
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/18/2019
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: 06/28/2021 Patient Sequence Number: 1
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