MAUDE Adverse Event Report: CTL MEDICAL CORPORATION PREFERENCE; CROSS LINK SET SCREW

Model Number 10-2900-070

Device Problem Material Separation (1562)

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

Event Date 05/02/2022

Event Type  malfunction  

Event Description

In a pedicle screw construct, where doctor used a crosslink, 2 set screws from the crosslink came out.Doctor backed out the set screw too much, while trying to engage the crosslink hook into the rod.This caused a 45 minute delay while surgeon looked for and recovered the set screws.No surgical technique was reported.No pre or post-op x-rays were provided.No harm or injury to the patient was reported.Case was completed without harm or injury to the patient.User error.Design of the connector is being enhanced to allow for the set screw to be "backed up" in order to account for potential user error.

• Brand Name: PREFERENCE
• Type of Device: CROSS LINK SET SCREW
• 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 Key: 15844599
• MDR Text Key: 307522511
• Report Number: 3009051471-2022-00005
• Device Sequence Number: 1
• Product Code: HWC
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 10-2900-070
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1