USS 03.603.108Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034712284), received between Jun 6, 2019 and May 4, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (1 report).

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

Recent adverse event reports

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

• MalfunctionMay 4, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT IN POST SURGERY, THE INSTRUMENT WAS BLOCKED UP AND COULD NOT BE DISASSEMBLED FOR CLEANING AND STERILIZATION. NO SURGERY IMPACT. NO PATIENT IMPACT. SURGERY DATE IS UNKNOWN. THIS REPORT IS FOR ONE (1) REMOBILIZATION TOOL FOR USS POLYAXIAL. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11768873 ↗
• MalfunctionNov 1, 2019Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2019 DURING AN UNKNOWN SURGERY THAT DR LIANTIS WAS REVISING USS POLY AND NEEDED TO MOBILIZE THE HEADS. THE DEVICE SEIZED UP WITH THE T HANDLE UNABLE TO TURN. AS THE HEADS COULD NOT BE MOBILIZED, THEY WERE RELIANT ON THE POLY HEADS BEING LOCKED IN A MONO POSITION TO REMOVE THE SCREWS. CONCOMITANT DEVICE REPORTED: UNKNOWN: SCREW - USS II (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN); UNKNOWN: SCREWDRIVER - USS II (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9268175 ↗
• MalfunctionJun 6, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING EVALUATION AT THE LOANER DEPARTMENT, IT WAS FOUND THAT THE REMOBILIZATION TOOL FOR UNIVERSAL SPINE SYSTEM (USS) POLYAXIAL HAS DAMAGED THREADS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REMOBILIZATION TOOL FOR USS POLYAXIAL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8675061 ↗