Reform Pedicle Screw System 39-RP-6535Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840019900911), received between Dec 16, 2020 and Dec 16, 2020 — classified as 1 injury.

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

• InjuryDec 16, 2020Break

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2020 IN THE UK, UTILIZING THE REFORM PEDICLE SCREW SYSTEM TO USE TWO SCREWS AND A ROD BENT TO A U-SHAPE TO BRIDGE ACROSS A PARS FRACTURE. A REDUCTION POLYAXIAL SCREW ASSEMBLY - Æ6.5MM X 35MM (39-RP-6535) WAS IMPLANTED ON THE LEFT SIDE OF L5 AND UPON ATTEMPTED INSERTION OF A REDUCTION POLYAXIAL SCREW ASSEMBLY - Æ6.5MM X 35MM (39-RP-6535) ON THE RIGHT SIDE THE PEDICLE BROKE. A HOOK WAS ATTEMPTED, BUT THE LAMINA FRACTURED. SUBSEQUENTLY, A REDUCTION POLYAXIAL SCREW ASSEMBLY - Æ5.5MM X 35MM WAS PLACED IN L4 ON THE RIGHT SIDE WITH THE ROD BENT TO TAKE THE LOAD OFF OF THE PARS FRACTURE. DURING FINAL TIGHTENING OF THE SET SCREW ON A RAMPED LAMINAR REDUCTION HOOK, MD, THE TIP OF THE LOCK-SCREW TORQUE DRIVER (39-RD-0060) BROKE. THE HOOK WAS REMOVED AND ANOTHER FROM THE SET USED. UPON FINAL TIGHTENING OF ONE OF THE LOCK-SCREWS THE TIP OF A SECOND LOCK-SCREW TORQUE DRIVER ALSO BROKE. THE BROKEN TIP WAS NOT ABLE TO BE RETRIEVED AND REMAINS IN THE HEAD OF THE POLYAXIAL SCREW, IMPLANTED IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11015699 ↗