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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOFIX SRL TRUELOK; TL, WIRE
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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 09/11/2020
Type of Reportable Event Malfunction
Event or Problem Description
Information provided states that on (b)(6) 2020 the patient had a truelok frame placed on right foot.The patient returned to clinic approximately 3 week after surgery for post-op follow-up.It was noticed at that time that 2 pins had broken.A revision surgery was performed to replace the pins.All pieces of the pins were successfully removed from the patient.
 
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Brand Name
TRUELOK
Common Device Name
TL, WIRE
Manufacturer (Section D)
ORTHOFIX SRL
via delle nazioni 9
bussolengo, verona 37012
IT  37012
MDR Report Key10677081
Report Number2183449-2020-00006
Device Sequence Number14230527
Product Code LXT
UDI-Device Identifier18033509853821
UDI-Public18033509853821
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/12/2020
Report Date (Section F) 09/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Model Number54-1215
Device Catalogue Number54-1215
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/14/2020
Date Report to Manufacturer09/14/2020
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date10/14/2020
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 Age63 YR
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