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

Model Number 015.XXXX

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Implant Pain (4561)

Event Date 02/14/2023

Event Type  malfunction  

Event Description

Follow-up x-ray images of a patient with a 6-level pedicle screw construct shows that the bottom right hand screw sheared at the neck region.There is no patient death or injury reported.No further incident information was provided after 2 attempts of reaching out to the representatives/informants.The cause is indeterminate without further information.This case is incidental.Typically, screw neck shearing is an unusual failure mode indicating that the load exceeded the material strength.In hindsight, carpentry would have required additional screws for load sharing when long constructs are involved as the sacrum iliac region does not have much cushion as the lumbar spine because of the lumbar discs.

• Brand Name: RAPAHEL
• 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: 16541810
• MDR Text Key: 311383771
• Report Number: 3009051471-2023-00005
• 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
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2023

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?: No
• Device Model Number: 015.XXXX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1