ReLine 10000481Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517511782), received between Mar 13, 2026 and Mar 13, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Fracture

  A REVISION CASE, SURGEON REMOVED A 7.5X55MM RELINE SCREW AND WANTED TO REPLACE WITH AN 8.5X55 SCREW. TAPPED WITH 7.5 TAPAS THE DOC ALWAYS UNDER SIZES BY 1MM. ADVANCED THE SCREW ABOUT 40/55MM INTO THE PEDICLE AND THE SCREW BECAME SO INCREDIBLY TIGHT IT WOULDN¿T MOVE ANY FURTHER. THE SURGEON HAD NO LUCK REVERSING THE SCREW WITH THE RELINE MAS RED HANDLE, SO ATTEMPTED A SHANK DRIVER FOR MORE LEVERAGE WITH A T-HANDLE. DRIVER TIP COMPLETELY BROKE OFF INSIDE THE SHANK. WE WERE UNABLE TO BACK THE SCREW COMPLETELY OUT. ATTEMPTED TO PUT A SHORT ROD AND SET SCREW INSIDE THE TULIP TO HELICOPTER THE SCREW OUT, HAD TO SNAP THE TOWERS OFF. ROD WAS LOOSE INSIDE THE TULIP, ASSUMING THE DRIVER THAT BROKE OFF WAS PREVENTING A RIGID CONNECTION AND THEREFORE UNABLE TO LOCK THE TULIP INTO A RIGID STATE. WE SUGGESTED TO TAKE THE ENDOSCOPE AND LOOK DIRECTING INTO THE TULIP TO SEE IF WE COULD REMOVE THE BROKEN DRIVER PIECE AND THEN RETRY THE ROD AND HELICOPTER METHOD. THE SURGEON DECIDED NOT TO. A SPINE REMOVAL SET WAS AVAILABLE FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24592929 ↗