MAUDE Adverse Event Report: CTL MEDICAL CORPORATION RAPHAEL; PEDICLE SCREW

Model Number 015.4352

Device Problem Material Deformation (2976)

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

Event Date 01/18/2023

Event Type  malfunction  

Event Description

The tulip of a raphael pedicle screw housing was bent laterally.X-ray images prior to screw removal show that there was an off-angled placement of the rod that could potentially lead to this resulting bent tulip.The subject implant was removed from the patient on (b)(6) 2023, this implant has since been returned to ctl for additional evaluation.Information regarding patient prior condition, anatomy, surgical technique, and overall construct carpentry was not provided.Additionally, no pre-op nor post-operation images were provided to the company.This particular failure that occurred is an unsual failure mode, which can only be the result of an excessive amount of load being placed on the housing.Such load could be from the torisonal load transfer of the overall construct due to patient motion and/or stored energy from the full spinal construct.From the information that was provided the source of the bending load after the surgery is not able to be determined and therefore the cause is deemed indeterminate.There was no injury to the patient, patient was revised on (b)(6) 2023.

• Brand Name: RAPHAEL
• Type of Device: PEDICLE 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 Key: 16388873
• MDR Text Key: 309984624
• Report Number: 3009051471-2023-00002
• 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: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 015.4352
• Device Lot Number: AEKFD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2023
• Date Manufacturer Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male