M.U.S.T. SACRAL ILIAC SCREW AND PELVIC TRAUMA SYSTEM
Received Nov 28, 2025 · Event occurred Nov 12, 2025
Report 3005180920-2025-01201 · MDR key 23669498
Device
Generic name
Must-si Ti-ha Screw 8x50mm, Full Thread, Sterile
Manufacturer
Medacta International SaModel number
03.65.506Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Implant Pain
- Implant Pain
Narrative
Additional Manufacturer Narrative
NO BATCH REVIEW AVAILABLE SINCE THE LOT IS STILL UNKNOWN. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.
Description of Event or Problem
DURING A SACRO-ILIAC JOINT FIXATION, APPROXIMATELY ONE MONTH AFTER THE PRIMARY SURGERY, THE PATIENT RETURNED REPORTING PAIN. X-RAYS SHOWED A RADIOLUCENT SHADOW AROUND THE PROXIMAL MUST-SI SCREW, LEADING THE SURGEON TO SUSPECT A POSSIBLE INFECTION.