BOOT ASSEMBLY 210080

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-25 for BOOT ASSEMBLY 210080 manufactured by Mako Surgical Corp..

Event Text Entries

[184825540] 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


[184825541] Fraying and sharp edges on boot. Surgeon worried about cutting patient. Patient was not cut. No harm was done. Case type: tka.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005985723-2020-00173
MDR Report Key9876713
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-25
Date of Report2020-04-01
Date of Event2020-02-28
Date Mfgr Received2020-03-19
Date Added to Maude2020-03-25
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 NameBOOT ASSEMBLY
Generic NameSTEREOTAXIC DEVICE, ROBOTICS
Product CodeOLO
Date Received2020-03-25
Model Number210080
Catalog Number210080
Lot Number201743102701
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMAKO SURGICAL CORP.
Manufacturer Address2555 DAVIE ROAD FORT LAUDERDALE FL 33317 US 33317


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2020-03-25

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