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

Model Number 015.3447

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 05/05/2023

Event Type  malfunction  

Event Description

This communication is intended as a retrospective notification.The sheared screw head was discovered during a 9 month post-op follow-up meeting dated (b)(6) 2023.(i.E.First surgery took 9 months prior to the said meeting date).Revision surgery to remove seperated hardware took place on (b)(6) 2023.In this case, the revision surgeon's replaced a 2 level (l3 to l5) construct with a 7 level (t11 to s1) which is a much longer construct.However, the specific part removed was not returned for evaluation.This seperatation can be potentially attributed to shearing, but shear failure incidents are typically rare, and when they do occur, it often suggests an underbuilt construct and/or failed fusion after 6 months.In this case, the revision surgeon's replaced a 2 level (l3 to l5) construct with a 7 level (t11 to s1) which is a much longer construct.Without access to before and after x-ray images, detailed patient anatomical information, and surgical procedure records from the initial surgery, the root cause of the failure cannot be determined.

• 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: 17337180
• MDR Text Key: 319442020
• Report Number: 3009051471-2023-00018
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 015.3447
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 88 KG