NA 498.290Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034789958), received between Sep 11, 2018 and Dec 10, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2019Break; Break

  THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. THE INVESTIGATION FOUND THE ROD WAS NOT BROKEN AS ORIGINAL THOUGHT BUT WAS CUT BY A TOOL WHICH IS NORMAL PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 9445859 ↗
• InjurySep 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGERY WAS PERFORMED ON (B)(6) 2008, FOR TREATMENT A L5 POSTERIOR RESECTION DUE TO A HEMANGIOMA WITH A L4-S1 POSTERIOR FUSION. DURING THIS PROCEDURE, THE PATIENT WAS IMPLANTED WITH THE (USS) UNIVERSAL SPINE SYSTEM IMPLANTS. THE PATIENT WAS IMPLANTED WITH ONE (1) 6.0MM/ 200MM TI ROD THAT WAS CUT IN HALF TO CONSTRUCT TWO RODS, TWO (2) TI LOW PROFILE TRANS-CONNECTORS, FOUR (4) NUTS, FOUR (4) COLLARS, TWO (2)8MM X 55MM SCREWS AND TWO (2) 9MM X 50MM SCREWS. ON (B)(6) 2008 PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM FOR A FOLLOW-UP PROCEDURE, WHERE THE PATIENT WAS IMPLANTED WITH ONE (1) SYNEX CAGE IMPLANT AT THE L5 SPINE DISC SPACE LEVEL. POST-OPERATIVE, THE PATIENT PRESENTED WITH A LUMBAR SPINE INFECTION. ON (B)(6) 2008, SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT PROCEDURE TO ADDRESS THE PATIENT'S INFECTION. NO PUS WAS FOUND INTRAOPERATIVELY. TISSUES APPEARED HEALTHY. CULTURES TAKEN DURING SURGERY WERE REPORTED WITH NO ORGANISMS SEEN ON GRAM STAIN. SURGERY WAS COMPLETED SUCCESSFULLY. THIS IS REPORT 4 OF 8 FOR (B)(4). THE ADDITIONAL 8 PARTS ARE BEING CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7863605 ↗