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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CTL MEDICAL CORPORATION TAURUS; SET SCREW
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CTL MEDICAL CORPORATION TAURUS; SET SCREW Back to Search Results
Model Number 51-0000-000
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/08/2019
Event Type  malfunction  
Event Description
Set screw was not able to advance down the screw housing with ease.Upon further inspection of the set screw the threads were deformed and some had separated from the set screw itself.Cause is indeterminate but can be potentially traced to user error.Typical modality is cross-threading of the housing with the set screw.This occurs when the axis of the set screw and the axis of the housing are misaligned.Surgeon replaced with new set screw and the case was completed as usual.No prior and post operative images were provided.Unknown patient anatomy and surgical technique used.No harm nor injury to the patient was reported.
 
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Brand Name
TAURUS
Type of Device
SET SCREW
Manufacturer (Section D)
CTL MEDICAL CORPORATION
4550 excel parkway
addison TX 75001
Manufacturer (Section G)
CTL MEDICAL CORPORATION
4550 excel parkway
addison TX 75001
Manufacturer Contact
tracy bui
4550 excel parkway
addison, TX 75001
MDR Report Key15723165
MDR Text Key304591494
Report Number3009051471-2019-00019
Device Sequence Number1
Product Code JDN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 11/03/2022
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
Device Model Number51-0000-000
Device Lot Number9G2BA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2019
Initial Date Manufacturer Received 11/13/2019
Initial Date FDA Received11/03/2022
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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