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

Model Number 015.3247

Device Problem Material Separation (1562)

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

Event Date 03/26/2021

Event Type  malfunction  

Event Description

Polyaxial screw tulip came apart from the screw body prior to revision surgery.This was a revision case.No reason for revision was provided.Original case done in april of 2017.No surgical technique was provided.No pre or post-op x-rays were provided.No patient anatomy was provided.No harm or injury to patient was reported.Case is indeterminate.Another pedicle screw was used as a replacement.Various potentials causes are [1] carpentry mismatch between desired construct curvature and implnat placement can induce excessive force on the tulip-rod assembly leading to tulip pop off; [2] patient activities or accidents could have led to the tulip popping off.No injury or harm to the patient was reported.

• Brand Name: RAPHAEL
• Type of Device: POLYAXIAL 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: 15814052
• MDR Text Key: 307507888
• Report Number: 3009051471-2021-00011
• 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: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 015.3247
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1