MAUDE Adverse Event Report: CALDERA MEDICAL INC. VERTESSA LITE; VLY2643

Model Number	VYL2643
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the expiration date displayed on the vly2643 packaging is not the real date.The implant shows it expires on february 29th, 2029.
Additional Manufacturer Narrative
It was discovered on lot # q02018, there is a labeling error regarding its expiration date, incorrectly printed as 02/29/2029, a date that does not exist.This issue arose from a software glitch in our labeling system, easylabel, which failed to account for leap years.The accurate expiration date for this lot is 02/28/2029.To rectify this issue, a new formula was developed that ensures the expiration date calculation correctly adjusts for non-leap years and accommodates a 1.5-year shelf life.In response to this error, the surgeon received a regulatory statement detailing the issue, and the current lot will be placed in quarantine for repackaging to ensure labeling accuracy.The manufacturing number is (b)(4).

• Brand Name: VERTESSA LITE
• Common Device Name: VLY2643
• Manufacturer (Section D): CALDERA MEDICAL INC.; 4360 park terrace dr.; suite 140; westlake village CA 91361
• Manufacturer (Section G): CALDER MEDICAL; 4360 park terrace dr. suite 14; westlake village CA 91361
• Manufacturer Contact: mahtab moberg ; 4360 park terrace dr. suite 140; westlake village, CA 91361
• MDR Report Key: 23493198
• Report Number: 3003990090-2025-01727
• Device Sequence Number: 15732109
• Product Code: OTO
• UDI-Device Identifier: 00890594000469
• UDI-Public: 00890594000469
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/06/2025

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: VYL2643
• Device Lot Number: Q02018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown