3.0 RIO? ROBOTIC ARM - MICS 209999

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-26 for 3.0 RIO? ROBOTIC ARM - MICS 209999 manufactured by Mako Surgical Corp..

Event Text Entries

[186105527] 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.
Patient Sequence No: 1, Text Type: N, H10


[186105528] The doctor revised a triathlon tibial insert from a 9mm to a 13mm and added some arthrex swivelocks medially due to left knee instability in mid-flexion. Original surgery was (b)(6) 2020. Rep provided primary and revision usage sheets and an x-ray and reported that no further information will be released by the hospital or surgeon.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005985723-2020-00178
MDR Report Key9883842
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2020-03-02
Date Mfgr Received2020-03-02
Date Added to Maude2020-03-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. ALESSANDRA CHAVEZ
Manufacturer Street2555 DAVIE ROAD
Manufacturer CityFORT LAUDERDALE FL 33317
Manufacturer CountryUS
Manufacturer Postal33317
Manufacturer Phone9546280700
Manufacturer G1MAKO SURGICAL CORP.
Manufacturer Street2555 DAVIE ROAD
Manufacturer CityFORT LAUDERDALE FL 33317
Manufacturer CountryUS
Manufacturer Postal Code33317
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name3.0 RIO? ROBOTIC ARM - MICS
Generic NameSTEREOTAXIC DEVICE, ROBOTICS
Product CodeOLO
Date Received2020-03-26
Model Number209999
Catalog Number209999
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMAKO SURGICAL CORP.
Manufacturer Address2555 DAVIE ROAD FORT LAUDERDALE FL 33317 US 33317


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-26

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