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

Model Number 015.1010

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 01/21/2019

Event Type  malfunction  

Event Description

The set screws show noticable deformation and shearing of the threads.The set screw appears to possibly be cross threaded by being forced down the tulip housing.The corresponding implant was sumitted with the same incident under mdr_3009051471-2019-0001.

• Brand Name: RAPHAEL
• Type of Device: SET SCREW (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: 15677436
• MDR Text Key: 305077694
• Report Number: 3009051474-2019-00002
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2022

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: 8M1AA
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2022
• Patient Sequence Number: 1