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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); Device Slipped (1584); Positioning Problem (3009)
Patient Problem Muscle/Tendon Damage (4532)
Event Date 04/27/2021
Event Type  Injury  
Manufacturer Narrative
Reported event: an event regarding inaccurate resection involving a mako pka software was reported. The event was not confirmed because the log/session files were not made available for review. Method & results: product evaluation and results: review of the case session files was not performed as case session data was not provided. -clinician review: no medical records were received for review with a clinical consultant. Product history review: a review of device history records shows that rob1079 was inspected on (b)(6) 2020 and the quality inspection procedures were completed with no reported discrepancies complaint history review: a review of complaints in trackwise related to p/n 219999, robot number: rob1079 shows 0 similar complaints for pka software - inaccurate resection. Conclusions: the exact cause of the event could not be determined because insufficient information was provided. Further information such as return of the case session/log data are needed to complete the investigation for determining root cause.
 
Event Description
Immediately after completing bone preparation, and posterior bone fragments were removed it was observed that the popliteal tendon was nicked and bleeding. Bleeding was able to be isolated and sutured with minimal delay in the case. Surgeon was requesting further information about if there have been other reported incidents of similar occurrences to help establish which cut he may have caused the nick on.
 
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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 Key11856022
MDR Text Key252431017
Report Number3005985723-2021-00092
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 05/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number219999
Device Catalogue Number219999
Device Lot NumberROB1079
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2021
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: 05/20/2021 Patient Sequence Number: 1
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