MAUDE Adverse Event Report: CTL MEDICAL CORPORATION; IMPLANT, FIXATION DEVICE, SPINAL

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2023

Event Type  malfunction  

Event Description

Report of pedicle screw neck shearing in a pedicle screw contruct was delivered to ctl on 02/17/2023 by the distributor representative.No injury or harm to the patient has been reported.No information regarding patient/surgeon/system usage has been provided.Company attempted to reach out twice without successful reponse.Failure modality (shearing of the screw neck) is an indication that construct was under built to withstand the loading conditions, but the case is inconclusive without additional incident information.

• Type of Device: IMPLANT, FIXATION DEVICE, SPINAL
• 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 Key: 16616100
• MDR Text Key: 312249089
• Report Number: 3009051471-2023-00006
• Device Sequence Number: 1
• Product Code: JDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1