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

Model Number 015.1010

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 11/05/2019

Event Type  malfunction  

Event Description

Set screw threads were sheared during the final tightening onto the pedicle screw housing.The overall construct anatomy and technique used to insert the set screw is unknown; therefore, the cause is undetermined.Typical set screw threads damage observed in the past resulted from either improper technique, carpentry, and/or misalignment between mating parts requiring excessive torque beyond 12 n-m to forcefully correct; and in the process, it could strip threads.Proper threading alignment should be confirmed before reducing the set screw/rod/ housing.Proper matching of curvature between rod and anatomy should be confirmed.Proper reduction between rod and housing should be confirmed.Any improper condition can cause stripping.No aforementioned information regarding surgical technique, no pre-op and post-op x-ray images were provided, and there was no reported harm/injury to the patient.The cause of this incident is indeterminate.

• Brand Name: RAPHAEL
• Type of Device: SET 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: 15893411
• MDR Text Key: 305265464
• Report Number: 3009051471-2019-00018
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2022

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?: Yes
• Device Model Number: 015.1010
• Device Lot Number: 9JSAC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Patient Sequence Number: 1