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

Model Number 015.3442

Device Problem Material Separation (1562)

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

Event Date 02/17/2023

Event Type  malfunction  

Event Description

Previous surgical intervention from 2019 with construct start from l3 down to s1, with fusion.Patient reported a fall on (b)(6) 2023.Follow-up appointment on (b)(6) 2023 detected s1 screw housing off the screw body.Revision surgery extended construct from l4 to s1 on (b)(6) 2023.Seperated parts were not returned for evaluation.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: 17337183
• MDR Text Key: 319297037
• Report Number: 3009051471-2023-00019
• 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: Company Representative
• 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: 015.3442
• Device Lot Number: 7KNHB
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 104 KG