TRUE/LOK EXTERNAL FIXATION SYSTEM WIRE 54-1215

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-11-13 for TRUE/LOK EXTERNAL FIXATION SYSTEM WIRE 54-1215 manufactured by Orthofix Inc..

Event Text Entries

[1012639] Provided information states that wire breakage was detected 26 days after the initial procedure. Patient had a second procedure to replace the broken wires.
Patient Sequence No: 1, Text Type: D, B5


[8164679] The device was discarded at the user facility, therefore evaluation by the manufacturer is not possible.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2183449-2008-00011
MDR Report Key1264642
Report Source07
Date Received2008-11-13
Date of Report2008-11-13
Date of Event2008-10-20
Date Mfgr Received2008-10-28
Date Added to Maude2009-08-07
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 FDA0
Event Location0
Manufacturer ContactRANDALL WHEELAND, DIRECTOR
Manufacturer Street1720 BRAY CENTRAL DR.
Manufacturer CityMCKINNEY TX 75069
Manufacturer CountryUS
Manufacturer Postal75069
Manufacturer Phone4697422529
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRUE/LOK EXTERNAL FIXATION SYSTEM WIRE
Generic NameFIXATION WIRE, 1.8MM X 400MM
Product CodeDZK
Date Received2008-11-13
Model Number54-1215
Catalog Number54-1215
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerORTHOFIX INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2008-11-13

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