Reform Pedicle Screw System 39-CH-0008Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840019928212), received between Jan 23, 2024 and Jan 23, 2024 — 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 18, 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.

• MalfunctionJan 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT AN L4-L5 POSTERIOR LUMBAR FUSION WAS PERFORMED ON (B)(6) 2023, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. IN THE FINAL STEP, THE DOCTOR RETRIEVED THE STANDARD TORQUE HANDLE (39-CH-0008) WITH A STANDARD SHAFT (39-RD-0060). THE INITIAL LEFT AND RIGHT SIDE SCREWS WERE (39-SB-6540 & 6545) WERE SOLIDLY PLACED IN ALL FOUR (4) PEDICLES. FOUR (4) MODULAR POLYAXIAL TULIP ASSEMBLIES (64-MT-0403) WERE THEN ATTACHED. A 40MM ROD (63-LT-5040) WAS PLACED IN THE TULIP. SET SCREWS (39-LS-0100) WERE THEN PLACED DOWN THE L4 TULIP UNTIL FORCE WAS INITIATED THAT WOULD RESULT IN THE FORCE LIMIT ON THE TORQUE LIMITING HANDLE TO RELEASE. UPON MAKING THE FINAL FORCED TURN, THE SHAFT OF THE DRIVER SHEARED OFF IN THE SET SCREW. THE DOCTOR WAS ABLE TO RETRIEVE THE BROKEN METAL. THE HANDLE/DRIVER COMBO WAS THEN EXCHANGED FROM A BACK-UP TRAY AND ALL FOUR (4) SET SCREW FUNCTIONED CORRECTLY. THERE WAS NO DELAY TO THE PROCEDURE RESULTING FROM THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563362 ↗