USS 04.602.950Recalls & reported problems
Synthes GmbH · 9.0MM TI DUAL CORE USS SCREW 50MM THRD LENGTH F/6.0MM RODS · 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 10705034735023), received between Jun 9, 2026 and Jun 9, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Integrity 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.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 9, 2026Material Integrity Problem
IT WAS REPORTED THAT 9.0MM TI DC USS SCR 50MM TH L F/6.0MM RD BROKE INTRAOPERATIVELY DURING A T10-PELVIS REVISION PROCEDURE. WHILE CHANGING THE LEFT ILIAC SCREW, THE SWIZZLE STICK BROKE ON THE SCREW HEAD, STRIPPING THE FIRST COUPLE OF THREADS OF THE SCREW. THE AFFECTED SIDE REQUIRED REPLACEMENT TWO TIMES AS THE ISSUE RECURRED. THE PRODUCT WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN. THERE WAS NO REPORTED PATIENT OR USER HARM, BUT THE SURGERY WAS PROLONGED BY 40 MINUTES AS THE PATIENT REMAINED UNDER ANESTHESIA LONGER DURING ATTEMPTS TO REMOVE THE BROKEN SCREW. THE EVENT RESULTED IN A CORRECTIVE INVASIVE PROCEDURE WHERE THE DEVICE WAS REPLACED/REVISED.
Patient problems: Insufficient Information
MAUDE report 25448833 ↗InjuryJun 9, 2026Material Integrity Problem
IT WAS REPORTED THAT 9.0MM TI DC USS SCR 50MM TH L F/6.0MM RD BROKE INTRAOPERATIVELY DURING A T10-PELVIS REVISION PROCEDURE. WHILE CHANGING THE LEFT ILIAC SCREW, THE SWIZZLE STICK BROKE ON THE SCREW HEAD, STRIPPING THE FIRST COUPLE OF THREADS OF THE SCREW. THE AFFECTED SIDE REQUIRED REPLACEMENT TWO TIMES AS THE ISSUE RECURRED. THE PRODUCT WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN. THERE WAS NO REPORTED PATIENT OR USER HARM, BUT THE SURGERY WAS PROLONGED BY 40 MINUTES AS THE PATIENT REMAINED UNDER ANESTHESIA LONGER DURING ATTEMPTS TO REMOVE THE BROKEN SCREW. THE EVENT RESULTED IN A CORRECTIVE INVASIVE PROCEDURE WHERE THE DEVICE WAS REPLACED/REVISED.
Patient problems: Insufficient Information
MAUDE report 25448825 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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