USS 04.607.280Recalls & reported problems
Synthes GmbH · 8.0MM TI USS CANC POLYAXIAL SCREW 70MM THREAD LENGTH · Class 2 · Implant
All models of USS (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034736570), received between Mar 10, 2023 and Mar 10, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Mechanical Problem” (2 reports).
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 16, 2026.
Most reported problems
Device problems
- Mechanical Problem2
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 10, 2023Mechanical Problem; Mechanical Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT SURGERY TO IMPLANT THE EXPEDIUM SACROILIAC USS. THEN, THE SURGEON RE-PERFORMED THE PROCEDURE DUE TO LOOSENING OF THE ILIAC SCREWS. THE SURGEON REMOVED THE 100MM SCREWS AND PLACED 70MM SCREWS, KEEPING THE SAME SYSTEM OF ILIAC CONNECTORS THAT THE PATIENT HAD PLACED IN THE INITIAL SURGERY. THIS REPORT INVOLVES ONE 8.0MM TI USS CANC POLYAXIAL SCREW 70MM THREAD LENGTH. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: Failure of Implant
MAUDE report 16523510 ↗InjuryMar 10, 2023Mechanical Problem; Mechanical Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT SURGERY TO IMPLANT THE EXPEDIUM SACROILIAC USS. THEN, THE SURGEON RE-PERFORMED THE PROCEDURE DUE TO LOOSENING OF THE ILIAC SCREWS. THE SURGEON REMOVED THE 100MM SCREWS AND PLACED 70MM SCREWS, KEEPING THE SAME SYSTEM OF ILIAC CONNECTORS THAT THE PATIENT HAD PLACED IN THE INITIAL SURGERY. THIS REPORT INVOLVES ONE 8.0MM TI USS CANC POLYAXIAL SCREW 70MM THREAD LENGTH. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: Failure of Implant
MAUDE report 16523504 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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