M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System 03.65.506Recalls & reported problems
Medacta International SA · M.U.S.T. SI Ti-HA Joint screw 8x50 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030880865), received between Nov 28, 2025 and Nov 28, 2025 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Implant Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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.
Patient problems: Implant Pain
MAUDE report 23669498 ↗
Other Sacroiliac Joint Fixation devices
- Firebird SI Fusion 18-1035SPOrthofix US LLC · Sacroiliac Joint Fixation1 recall1 report
- iFuse TORQ Implant System 10065TSi-Bone Inc. · Sacroiliac Joint Fixation1 recall1 report
- iFuse TORQ Implant System 10060TSi-Bone Inc. · Sacroiliac Joint Fixation1 recall1 report
- Firebird SI Fusion 18-2050SPOrthofix US LLC · Sacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-1065SPOrthofix US LLC · Sacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-2065SPOrthofix US LLC · Sacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-2045SPOrthofix US LLC · Sacroiliac Joint Fixation1 recall0 reports
- iFuse TORQ Implant System 10055TSi-Bone Inc. · Sacroiliac Joint Fixation1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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