SMART-TOE * ST0-16

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-09-25 for SMART-TOE * ST0-16 manufactured by Memometal.

Event Text Entries

[15190247] Portion of implant removed from foot.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1489927
MDR Report Key1489927
Date Received2009-09-25
Date of Report2009-09-25
Date of Event2009-09-18
Report Date2009-09-25
Date Reported to FDA2009-09-25
Date Added to Maude2009-10-05
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSMART-TOE
Generic NameIMPLANT, ORTHOPEDIC, TOE
Product CodeLZJ
Date Received2009-09-25
Model Number*
Catalog NumberST0-16
Lot Number07338-10-0698A-M51
ID Number*
Device AvailabilityN
Device Age1 DY
Device Sequence No1
Device Event Key0
ManufacturerMEMOMETAL
Manufacturer Address6000 POPLAR AVENUE, SUITE 110 MEMPHIS TN 38119 US 38119


Patients

Patient NumberTreatmentOutcomeDate
10 2009-09-25

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