Reform Ti CT Modular MIS Pedicle Screw System 64-SP-1700Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840019942454), received between Jul 17, 2023 and Jun 30, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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

• InjuryJun 30, 2026Fracture

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2026. AFTER PLACEMENT OF THE SCREW THE SURGEON WENT BACK TO ADJUST. THE ADJUSTMENT COULD NOT BE MADE WITH THE ADJUSTMENT DRIVER (64-SP-0601) SO HE ASKED FOR THE GLOBUS ROBOT DRIVER (75-RT-1750) SO MUCH FORCE WAS APPLIED WHEN TRYING TO TURN THE SCREW THE DRIVER SNAPPED NEAR HANDLE. WE THEN TRIED USING THE (64-SP-1700) AND THE SAME RESULT OCCURRED. WE THEN PLACED A ROD IN THE TULIP AND ATTEMPTED TO USE A SHUKLA TO HELICOPTER IT OUT. THIS RESULTED IN THE NECK OF THE SCREW SNAPPING. NOW WITH THE SHANK OF THE SCREW LEFT IN THE PATIENT WE USED A SHUKLA BROKEN STRIPPED SCREW EXTRACTOR AND WERE ABLE TO REMOVE THE REMAINDER OF THE SCREW. THERE WAS NO PATIENT INJURY, BUT THERE WAS A TWENTY (20) MINUTE DELAY TO THE PROCEDURE AS A RESULT OF THE MALFUNCTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25667761 ↗
• InjuryJul 17, 2023Break; Break

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2023, UTILIZING THE REFORM TI MIS CT PEDICLE SCREW SYSTEM. UPON SCREW INSERTION THE TIP OF TWO POLYAXIAL DRIVER ASSEMBLY, CANNULATED REFORM MIS SYSTEM (64-SP-1700) AND ONE ADJUSTMENT DRIVE, REFORM MIS PEDICLE SYSTEM (64-SP-0601) BROKE. A 07.5MM X 45MM REFORM TI MODULAR CANNULATED SCREW (64-SK-7545) ALSO SHEARED AT THE NECK. THE SHEARED SCREW WAS REMOVED AND REPLACED. NO BROKEN TIPS WERE LEFT IN THE PATIENT, BUT THERE WAS A 45-55 MINUTE DELAY TO THE PROCEDURE DUE TO THE MALFUNCTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17337171 ↗
• InjuryJul 17, 2023Break; Break

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2023, UTILIZING THE REFORM TI MIS CT PEDICLE SCREW SYSTEM. UPON SCREW INSERTION THE TIP OF TWO POLYAXIAL DRIVER ASSEMBLY, CANNULATED REFORM MIS SYSTEM (64-SP-1700) AND ONE ADJUSTMENT DRIVE, REFORM MIS PEDICLE SYSTEM (64-SP-0601) BROKE. A 07.5MM X 45MM REFORM TI MODULAR CANNULATED SCREW (64-SK-7545) ALSO SHEARED AT THE NECK. THE SHEARED SCREW WAS REMOVED AND REPLACED. NO BROKEN TIPS WERE LEFT IN THE PATIENT, BUT THERE WAS A 45-55 MINUTE DELAY TO THE PROCEDURE DUE TO THE MALFUNCTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17337170 ↗