Reform Ti CT Modular MIS Pedicle Screw System 64-RD-9010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840019942515), received between Dec 12, 2022 and Mar 1, 2024 — classified as 3 injuries.

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

• InjuryMar 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED IN AUSTRALIA ON (B)(6) 2023, UTILIZING THE REFORM TI MIS CT PEDICLE SCREW SYSTEM. DURING INSERTION OF A ROD, THE TIP OF THE ROD INSERTER ASSEMBLY (B)(6) BROKE WHILE TRYING TO MANIPULATE IT INTO POSITION. THE BROKEN FRAGMENT PIECE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED AS USUAL AS THE ROD WAS IN PLACE WHEN THE TIP BROKE. THERE WAS A 5 MINUTE DELAY TO THE PROCEDURE RESULTING FROM THE BROKEN INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18818735 ↗
• InjuryMar 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED IN (B)(6) ON (B)(6), UTILIZING THE REFORM TI MIS CT PEDICLE SCREW SYSTEM. DURING INSERTION OF A ROD, THE TIP OF THE ROD INSERTER ASSEMBLY (64-RD-9010) BROKE WHILE TRYING TO MANIPULATE IT INTO POSITION. THE PROCEDURE WAS COMPLETED AS USUAL AS THE ROD WAS IN PLACE WHEN THE TIP BROKE. THERE WAS A 5-10 MINUTE DELAY TO THE PROCEDURE RESULTING FROM THE BROKEN INSTRUMENT. A SECOND SURGERY WAS PERFORMED ON AN UNKNOWN DATE TO RECOVER THE BROKEN FRAGMENT FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18817676 ↗
• InjuryDec 12, 2022Break; Entrapment of Device

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2022, UTILIZING THE REFORM MIS CT PEDICLE SCREW SYSTEM. WHEN TIGHTENING DOWN ON ONE OF THE LOCK SCREWS FOR THE SECOND ROD INSERTED, THE TIP OF THE ROD INSERTER ASSEMBLY REFORM MIS (39-RD-9010) BROKE. THE DOCTOR CONTINUED TIGHTENING DOWN ON THE ROD LEAVING THE BROKEN INSERTER TIP LOCKED UNDER THE ROD. THERE WAS NO DELAY TO THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15958933 ↗