USS 04.602.890Recalls & reported problems
Synthes GmbH · 8.0MM TI DUAL CORE USS SCREW 90MM THRD LENGTH F/6.0MM RODS · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034734965), received between Apr 6, 2022 and Apr 6, 2022 — classified as 2 malfunctions.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Integrity Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT ON (B)(6) 2022, WHILE INSERTING TWO(2) 8X90MM SCREWS INTO THE ILLIUM WITH THE ARTICULATING T-HANDLE THE HEAD OF SCREWS SHEARED OFF. THE SCREWS AND FRAGMENTS WERE REMOVED AND REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT INVOLVES ONE (1) 8.0MM TI DUAL CORE USS SCREW 90MM THRD LENGTH F/6.0MM RODS. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14026755 ↗MalfunctionApr 6, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT ON (B)(6) 2022, WHILE INSERTING TWO(2) 8X90MM SCREWS INTO THE ILLIUM WITH THE ARTICULATING T-HANDLE THE HEAD OF SCREWS SHEARED OFF. THE SCREWS AND FRAGMENTS WERE REMOVED AND REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT INVOLVES ONE (1) 8.0MM TI DUAL CORE USS SCREW 90MM THRD LENGTH F/6.0MM RODS. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14025434 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.