Reform Pedicle Screw System 39-SP-0730Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815362022016), received between Jul 12, 2021 and Aug 18, 2025 — classified as 2 injuries, 1 malfunction.

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.

• MalfunctionAug 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2024, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2025 TO EXTEND THE EXISTING CONSTRUCT. DURING THE PROCEDURE IT WAS NOTED THAT ONE OF THE Ø6.5MM X 50MM REFORM TI MODULAR NON-CANNULATED - NON-FLUTED SCREW (39-SG-6550) WAS FRACTURED. THE BROKEN SCREW WAS REMOVED AND REPLACED WITH NEW HARDWARE. IT WAS ALSO NOTED THAT WHILE IMPLANTING A SCREW THE TIP OF THE T20 POLYAXIAL DRIVER REFORM PEDICLE SCREW SYSTEM (39-SP-0730) BROKE. THE TIP WAS REMOVED AND THE PROCEDURE COMPLETED WITH NO FURTHER ISSUE AND NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22834571 ↗
• InjuryApr 18, 2022Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, TO ADDRESS A BROKEN REFORM PEDICLE SCREW, ATTRIBUTED TO NON-FUSION. THE ORIGINAL IMPLANTATION DATE WAS NOT PROVIDED. THE EXISTING CONSTRUCT WAS REMOVED AND UPON ATTEMPTED INSERTION OF A OF A REFORM 10.5 X 50MM POLYAXIAL PEDICLE SCREW (39-PA-1050) IN A NEWLY PREPARED PEDICLE, THE TIP OF THE REFORM POLYAXIAL DRIVER (HXX-39-0001) BROKE OFF IN THE HEAD OF THE SCREW. THE SCREW WAS THEN REMOVED AND SUCCESSFULLY REPLACED WITH ANOTHER SCREW USING A SECOND DRIVER IN THE SET. SUBSEQUENTLY, WHILE IMPLANTING ANOTHER REFORM 10.5 X 50MM POLYAXIAL PEDICLE SCREW (39-PA-1050) THE SCREW WAS 85% SEATED WHEN THE HEAD OF THE SCREW SHEARED OFF AT THE NECK BETWEEN THE SCREW HEAD AND THREADED SHAFT. THE THREADED SHAFT WAS LEFT IN THE PATIENT'S BONE AND THE PEDICLE WAS LEFT UN-FIXATED. THE CONSTRUCT WAS SUCCESSFULLY COMPLETED WITH NO HARM TO THE PATIENT. THERE WAS A DELAY OF ONE HOUR BECAUSE OF THE REPORTED MALFUNCTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14138140 ↗
• InjuryJul 12, 2021Break

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. WHILE ATTEMPTING TO INSERT A REFORM PEDICLE SCREW HA COATED, THE TIP OF THE DRIVER BROKE. THE BROKEN TIP WAS LEFT IN THE HEAD OF THE SCREW, IMPLANTED IN THE PATIENT. THERE WAS NO DELAY TO THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 12150550 ↗