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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL INSERT ONLAY TRIAL-SIZE 6-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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MAKO SURGICAL CORP. TIBIAL INSERT ONLAY TRIAL-SIZE 6-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM Back to Search Results
Catalog Number 170706-1
Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978); Insufficient Information (3190)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 01/17/2017
Event Type  malfunction  
Manufacturer Narrative
Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
 
Event Description
During removal of the insert trial, it broke.The doctor was able to remove the rest of the trial without issue.The event took place after the doctor had verified the fit of the trials there was a patient involved but there was no effect on the patient.There was only a 1 to 2 minute delay on the case.
 
Manufacturer Narrative
An event regarding crack/fracture involving a mako trial was reported.The event was confirmed.Method & results: -device evaluation and results: the device was returned in used condition.There are scratches in various areas of the trial.There is a piece broken off from the left corner of the trial.Examination of the returned device with material analysis engineer indicated that the device fractured due to an overload condition.-medical records received and evaluation: not performed as patient factors did not contribute to the event.-device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review: there has been no other event for the lot referenced.Conclusions: the event was confirmed as per visual inspection of the returned device which shows that there is a piece broken off from the left corner of the trial.Further consultation of the returned device with material analysis engineer indicated that the device fractured due to an overload condition.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
During removal of the insert trial, it broke.The doctor was able to remove the rest of the trial without issue.The event took place after the doctor had verified the fit of the trials there was a patient involved but there was no effect on the patient.There was only a 1 to 2 minute delay on the case.
 
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Brand Name
TIBIAL INSERT ONLAY TRIAL-SIZE 6-8MM
Type of Device
PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6308932
MDR Text Key66734777
Report Number3005985723-2017-00053
Device Sequence Number1
Product Code NPJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090763
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number170706-1
Device Lot Number12210213
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received03/27/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/08/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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