MAUDE Adverse Event Report: CTL MEDICAL CORPORATION VALEO II LL; OSTEOTOME

Model Number 91.020.4015

Device Problem Material Separation (1562)

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

Event Type  malfunction  

Event Description

Box cutter osteotome was returned broken at the cutting edge without any complaint from the field.It was noticed internally at receiving.No information on how to break occured was provided by the rep.No case details were provided.No surgical technique was provided.No pre or post-op x-rays were provided.No harm or injury to patient was reported.Cause is indeterminate.

• Brand Name: VALEO II LL
• Type of Device: OSTEOTOME
• 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: 15844684
• MDR Text Key: 306993915
• Report Number: 3009051471-2022-00002
• 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: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 91.020.4015
• Device Lot Number: 700176151
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1