M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System 03.65.503Recalls & reported problems
Medacta International SA · M.U.S.T. SI Ti-HA Joint screw 8x35 · 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 07630030880834), received between Apr 13, 2023 and Apr 13, 2023 — 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.
Most reported problems
Device problems
- No Apparent Adverse Event1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 13, 2023No Apparent Adverse Event; No Apparent Adverse Event
REVISION SURGERY AFTER ABOUT 3 YEARS DUE TO PAIN, THE SURGEON WANTED TO REMOVE THE 3 ILIAC SCREWS IN ORDER TO SOLVE THE PAIN ISSUE. DURING THE SCREW REMOVAL THE 3 SCREWS BROKE.
Patient problems: Pain
MAUDE report 16732222 ↗
Other Sacroiliac Joint Fixation devices
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- 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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