USS 04.607.402Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034736655), received between May 2, 2017 and Jan 30, 2020 — classified as 1 injury, 2 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2020Break; Break

  LIBERTAS: IT WAS REPORTED ON (B)(6) 2020, A IMPLANT HOLDER DOES NOT FUNCTION AND A TITANIUM POLYAXIAL HEAD WAS FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF A RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9649429 ↗
• MalfunctionJan 30, 2020Break; Break

  LIBERTAS: IT WAS REPORTED ON (B)(6) 2020, A IMPLANT HOLDER DOES NOT FUNCTION AND A TITANIUM POLYAXIAL HEAD WAS FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF A RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9649427 ↗
• InjuryMay 2, 2017Unintended Movement; Unintended Movement

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT IS REPORTED PATIENT WAS IMPLANTED WITH THE UNIVERSAL SPINE SYSTEM (USS) II AT UNKNOWN LEVELS ON (B)(6) 2017. X-RAY TAKEN ON (B)(6) 2017 REVEALED THAT THE POLYAXIAL 3D HEAD AND THE COLLAR HAD BECOME LOOSE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2017 FOR REVISION. IT IS NOT KNOWN WHAT WAS IMPLANTED DURING THE REVISION PROCEDURE. CONCOMITANT DEVICES REPORTED: TITANIUM NUT (PART 499.294, QUANTITY 1). THIS REPORT IS FOR ONE (1) USS POLYAXIAL 3D HEAD. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 6538940 ↗