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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO ROBOTIC ARM - MICS ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MAKO SURGICAL CORP. 3.0 RIO ROBOTIC ARM - MICS ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 209999
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2021
Event Type  malfunction  
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
When doing bone registration the fossa could not be verified even after redoing registration. Surgeon asked to continue and when trying to bring the reamer into the acetabulum the inclination and version was reached outside of the incision. Case was completed manually. Surgical delay: > 30 minutes. Case type / application: tha.
 
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Brand Name3.0 RIO ROBOTIC ARM - MICS
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 Key12092380
MDR Text Key260025155
Report Number3005985723-2021-00117
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,Followup
Report Date 08/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number209999
Device Catalogue Number209999
Device Lot NumberROB424
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 Received07/22/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/31/2016
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: 06/30/2021 Patient Sequence Number: 1
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