Reform Ti Modular 39-SK-6540Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840019933612), received between Dec 21, 2022 and Jul 20, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 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.

• InjuryJul 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2023, BY DR. (B)(6) UTILIZING THE REFORM TI MODULAR PEDICLE SCREW SYSTEM. THE SCRUB TECH ASSEMBLED THE Ø6.5MM X 40MM REFORM TI MODULAR CANNULATED SCREW (39-SK-6540) AND THE REFORM TI MODULAR TOWER TULIP (39-MT-0403) ON THE BACK TABLE. FOLLOWING ASSEMBLY, SHE PUSHED AND PULLED ON THE TULIP PRIOR TO LOADING ON THE DRIVER. THE SURGEON THEN INSERTED THE K-WIRE WITH A MAZAR ROBOT ON THE RIGHT SIDE AND INSERTED SCREWS IN BOTH L4 & L5 AND THEN INSERTED LEFT SIDE SCREWS. THE ROD WAS PLACED ON THE LEFT SIDE, LOCKING CAPS WERE ASSEMBLED AND TORQUED. THE PHYSICIAN ASSISTANT WAS THEN USING THE GOLD SHAFT HEIGHT ADJUSTER AND WHEN THE HEIGHT ADJUSTER WAS PULLED OFF, THE TULIP HAD DISASSEMBLED AND WAS STILL IN THE ADJUSTER. THE PEDICLE SCREW WAS THEN REMOVED AND REPLACED WITH A NEW SCREW/TULIP ASSEMBLY OF THE SAME SIZE AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER INCIDENT. THERE WAS NO PATIENT INJURY, BUT A 2 1/2 MINUTE DELAY TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17365404 ↗
• InjuryDec 21, 2022Use of Device Problem

  IT WAS REPORTED THAT A ONE-LEVEL PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE, UTILIZING THE REFORM MIS TI CT PEDICLE SCREW SYSTEM. IT WAS NOTED DURING FINAL RADIOGRAPHS TAKEN DURING THE PROCEDURE SHOW THAT ONE OF THE MODULAR POLYAXIAL TULIP ASSEMBLY REFORM MIS PEDICLE SCREW ((B)(4)) WAS NOT ASSEMBLED TO THE SCREW. THE SCREW WAS THEN REMOVED AND REPLACED WITH A NEW SCREW/TULIP ASSEMBLY. THERE WAS NO PATIENT INJURY BUT A 20-30 MINUTE DELAY RESULTED. THE DISASSEMBLED PRODUCT WAS DISCARDED IN THE OPERATING ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16024223 ↗