MAUDE Adverse Event Report: CTL MEDICAL CORPORATION CEZANNE; DISC SHAVER

Model Number 103.7110

Device Problems Material Separation (1562); Device Damaged Prior to Use (2284)

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

Event Type  malfunction  

Event Description

Lumbar disc shaver mid shaft separated at the weld region.This was discovered prior to surgery.No precoedural events related to this break.No harm or injury to patient.Potential handling error.Cause indeterminate.

• Brand Name: CEZANNE
• Type of Device: DISC SHAVER
• Manufacturer (Section D): CTL MEDICAL CORPORATION; 4550 excel pkwy; ste 300; addison TX 75001
• Manufacturer (Section G): CTL MEDICAL CORPORATION; 4550 excel pkwy; ste 300; addison TX 75001
• Manufacturer Contact: nicole conforti ; 4550 excel pkwy; ste 300; addison, TX 75001
• MDR Report Key: 15801707
• MDR Text Key: 306793524
• Report Number: 3009051471-2021-00006
• Device Sequence Number: 1
• Product Code: LXH
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 103.7110
• Device Lot Number: 15ESSBBB
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1