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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CTL MEDICAL CORPORATION VALEO II LL; INNER SHAFT
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CTL MEDICAL CORPORATION VALEO II LL; INNER SHAFT Back to Search Results
Model Number 91.020.1002
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
In the lumbar cage straight inserter, the inner shaft's threaded distal tip broke off in cage while surgeon was impacting.No surgical tecnique was provided.No patient anatomy was provided.No pre or post-op x-rays were provided.Surgery was completed.When the axis of the instrument is not held straight, and wobbles while maletting, may cause the distal tip to break.Potential user error.(this failure could exist in high usage wear-and-tear or misuse outside prescribed surgical technique such as poor disc prep, forcible cage insertion, axial mismatch during insertion, and/or in-situ repositioning.).
 
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Brand Name
VALEO II LL
Type of Device
INNER SHAFT
Manufacturer (Section D)
CTL MEDICAL CORPORATION
4550 excel pkwy
ste 300
addison TX 75001
Manufacturer (Section G)
CTL MEDICAL CORPORATION
4550 excel pkwy
ste 300
addison TX 75001
Manufacturer Contact
nicole conforti
4550 excel pkwy
ste 300
addison, TX 75001
2145455820
MDR Report Key15814053
MDR Text Key307687234
Report Number3009051741-2021-00014
Device Sequence Number1
Product Code LXH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/16/2022
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? No
Device Model Number91.020.1002
Device Lot Number000090
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/17/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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