MalfunctionJDW
PROCALLUS SHORT CENTRAL BODY
Received Dec 16, 2025 · Event occurred Aug 26, 2025
Report 9680825-2025-00053 · MDR key 23815333
Device
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
41 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DEVICE INVOLVED IN THIS EVENT HAS NOT BEEN RETURNED FOR INVESTIGATION, BUT IT HAS BEEN REQUESTED TO RETURN. IF THE DEVICE IS RETURNED AN INVESTIGATION WILL BE COMPLETED AND A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
AS PER THE REPORTER, DURING THE SURGICAL PROCEDURE, THEY EXPERIENCED A DISASSEMBLING OF COMPONENTS OF THE DEVICE. THIS CAUSED A SURGICAL DELAY OF 30 MINUTES DUE TO THE DEVICE REPLACEMENT. NO PATIENT HARM WAS REPORTED.