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

Model Number 103.7154

Device Problem Material Separation (1562)

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

Event Date 10/13/2021

Event Type  malfunction  

Event Description

Disc shaver broke at distal end when being rotated between disc space and removing material from end plates.Part not returned.No surgical technique provided.No patient anatomy provided.No pre or post-op x-rays provided.No harm or injury to the patient was reported.Case was completed.Cause indeterminate.Failure mode could not be replicated during testing.Unknown loading and/or usage condition exceeded material strength.Therefore the exact cause is indeterminate.Also, the lot no # is not provided, and the part is not returned.So engineering conclusion is 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 ; 2145455820
• MDR Report Key: 15814139
• MDR Text Key: 307662802
• Report Number: 3009051471-2021-00025
• 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
• Type of Report: Initial
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 103.7154
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1