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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 Incorrect, Inadequate or Imprecise Resultor Readings (1535); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/20/2021
Event Type  malfunction  
Event Description
As reported via case number. Mps reported inaccurate cuts in multiple cases. Mps confirmed no issues with registration, camera is clean and in a good location. Mps stated the main issue is with the distal femur cut. Case completed robotically. As reported via complaint form: experiencing deep cuts, especially with the distal femoral cut. Robot would not show red on the cut, but when checked with planar probe, the cut would be 2mm or more deep. We have seen cuts as deep as 2. 5mm. When trialing cuts were confirmed to in fact be deep. Several times the only deep cut was the distal cut, but we have seen it on others as well. No surgical delay. Case type / application: tka.
 
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. Device not returned.
 
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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
anna ryan
raheen business park
limerick NA
EI   NA
61498200
MDR Report Key13240093
MDR Text Key283843546
Report Number3005985723-2022-00006
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 04/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number219999
Device Catalogue Number219999
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 01/12/2022 Patient Sequence Number: 1
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