MAUDE Adverse Event Report: SKYTRON SKYTRON; 40" CARBON FIBER EXTENSION

Model Number	4-030-40
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A skytron authorized representative visited the customer facility and confirmed that the carbon fiber extension is working as intended.Based on the skytron evaluation of the information that is available, determined that probable cause is not related to a device defect.
Event or Problem Description
A skytron authorized representative submitted a complaint describing an incident at a customer facility where a skytron carbon fiber extension detached from a surgical table while the surgeon was trying to re-position the patient.There was no patient injury reported as a result of the incident.

• Brand Name: SKYTRON
• Common Device Name: 40" CARBON FIBER EXTENSION
• Manufacturer (Section D): SKYTRON; 5085 corporate exchange blvd s; grand rapids MI 49512
• Manufacturer (Section G): CQ MEDICAL; 1401 8th st se; orange city IA 51041
• Manufacturer Contact: lex hejna ; 5085 corporate exchange blvd; grand rapids, MI 49512 ; 6166562900
• MDR Report Key: 21922447
• Report Number: 1825014-2025-00001
• Device Sequence Number: 4084914
• Product Code: FQO
• UDI-Device Identifier: 10841736112714
• UDI-Public: 10841736112714
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2025

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
• Operator of Device: Health Professional
• Device Model Number: 4-030-40
• Device Catalogue Number: 4-030-40
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown