Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOFIX SRL TRUELOK; TL, WIRE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ORTHOFIX SRL TRUELOK; TL, WIRE Back to Search Results
Model Number 54-1215
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/01/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Information provided states that on (b)(6) 2019 the patient had a truelok frame placed on right foot and ankle.The patient returned to clinic approximately 2 weeks after surgery for post op follow-up.It was noticed at that time that a strut and two pins had broken.A revision surgery was performed to replace the pins and strut.All pieces of the pins were successfully removed from the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRUELOK
Common Device Name
TL, WIRE
Manufacturer (Section D)
ORTHOFIX SRL
via delle nazioni 9
bussolengo, 37012
IT  37012
MDR Report Key9312523
Report Number2183449-2019-00008
Device Sequence Number1961996
Product Code LXT
UDI-Device Identifier18033509853821
UDI-Public18033509853821
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Importer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/06/2019
Report Date (Section F) 10/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Device Model Number54-1215
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/14/2019
Event Location Home
Date Report to Manufacturer10/07/2019
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/12/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age66 YR
-
-