NA 498.545Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034790992), received between Apr 13, 2018 and Apr 13, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT UNDERWENT A TRANSPEDICULAR FIXATION DUE TO DORSAL TRAUMA ON UNKNOWN DATE IN 2012. ON UNKNOWN DATE IT WAS DETERMINED THAT TWO (2) UNIVERSAL SPINE SYSTEM (USS) 5.0MM TITANIUM SIDE-OPENING SCREWS WERE BROKEN. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE THE TWO (2) BROKEN SCREWS. IT WAS FURTHER REPORTED THE TIPS OF THE BROKEN SCREWS REMAIN EMBEDDED IN PATIENT BONE. CONCOMITANT DEVICES REPORTED: ROD (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN), NUT (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN), WASHER (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN), STAPLE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN), SCREW COLLAR (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN).THIS REPORT IS FOR ONE (1) 5.0MM TITANIUM SIDE-OPENING SCREW.THIS IS REPORT 2 OF 2 FOR (B)(6).

  Patient problems: No Code Available

  MAUDE report 7430891 ↗
• InjuryApr 13, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT UNDERWENT A TRANSPEDICULAR FIXATION DUE TO DORSAL TRAUMA ON UNKNOWN DATE IN 2012. ON UNKNOWN DATE IT WAS DETERMINED THAT TWO (2) UNIVERSAL SPINE SYSTEM (USS) 5.0MM TITANIUM SIDE-OPENING SCREWS WERE BROKEN. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE THE TWO (2) BROKEN SCREWS. IT WAS FURTHER REPORTED THE TIPS OF THE BROKEN SCREWS REMAIN EMBEDDED IN PATIENT BONE. CONCOMITANT DEVICES REPORTED: ROD (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN), NUT (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN), WASHER (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN), STAPLE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN), SCREW COLLAR (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 5.0MM TITANIUM SIDE-OPENING SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7430665 ↗