Reform Ti Modular 39-SK-6545Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840019933629), received between May 17, 2023 and Mar 18, 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 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT A L4/L5/S2A1 PROCEDURE WAS PERFORMED IN AUSTRALIA ON (B)(6) 2022, UTILIZING THE REFORM TI MODULAR CANNULATED PEDICLE SCREW SYSTEM. SUBSEQUENTLY, THE PATIENT PRESENTED WITH PAIN AND RADIOGRAPHS SHOWED COMPRESSION OF THE CONSTRUCT AND A BROKEN SCREW IN L4, RIGHT SIDE. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2024, DURING WHICH THE BROKEN 45MM REFORM TI MODULAR CANNULATED SCREW (B)(6) WAS CONFIRMED AND IT WAS NOTED THAT THE LEFT SIDE L4 SCREW SHOWED SIGNIFICANT LOOSENING. BOTH THE PROXIMAL AND DISTAL ENDS OF THE BROKEN SCREW WERE REMOVED AND REPLACED ALONG WITH THE LOOSE SCREW ON THE RIGHT SIDE. IN ADDITION, SCREWS WERE ALSO PLACED IN THE TWO LEVELS ABOVE WITH THE REMAINDER OF THE ORIGINAL CONSTRUCT LEFT IN PLACE. IMAGE PROVIDED SHOWS CAGE MIGRATION IN THE DISC SPACE JUST UNDER THE BROKEN SCREW.

  Patient problems: Implant Pain

  MAUDE report 18924238 ↗
• InjuryOct 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL L5/S1 IMPLANTATION OF MODULAR CANNULATED SCREWS ON (B)(6) 2023, IN AUSTRALIA. SUBSEQUENTLY, THE PATIENT PRESENTED WITH PAIN, AND IT WAS IDENTIFIED THAT THE SCREWS IN S1 HAD BROKEN. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2023 DURING WHICH IT WAS NOTED THAT LEFT S1 WAS BROKEN MID-SHAFT (DISTAL TO THE DIAMETER TRANSITION). THE PROXIMAL END OF 39-SK-6550 WAS EXPLANTED, THE DISTAL FRAGMENT REMAINS IN THE PATIENT. A 39-SK-7580 SHANK (WITH TULIP AND SET SCREW) WERE IMPLANTED AT THE ILIAC CREST FOR ADDITIONAL STRENGTH AND TO AVOID THE FRAGMENT. NO NEW SCREWS IMPLANTED AT S1 ON EITHER SIDE. THE RIGHT S1 SHANK WAS BROKEN AT APPROXIMATELY THE DIAMETER-TRANSITION. THE PROXIMAL END OF 39-SK-6545 WAS EXPLANTED AND THE DISTAL FRAGMENT REMAINS IN THE PATIENT. A 39-SK-7570 SHANK (WITH TULIP AND SET SCREW) WERE IMPLANTED AT THE ILIAC CREST ON THE RIGHT SIDE FOR ADDITIONAL STRENGTH AND TO AVOID THE FRAGMENT. THE L5 SCREWS WERE REMOVED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17976976 ↗
• InjuryMay 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2023, UTILIZING THE REFORM TI MIS PEDICLE SCREW SYSTEM. THE MODULAR POLYAXIAL TULIP ASSEMBLY (64-MT-0403) WAS POPPED ONTO THE Ø6.5MM X 45MM REFORM TI MODULAR CANNULATED SCREW (39-SK-6545) IN THE CADDY. THE TECH THEN PULLED ON THE BONE SCREW TO CHECK FOR PROPER ASSEMBLY. THE ASSEMBLED SCREW AND TULIP WAS THEN INSERTED WITH THE POLYAXIAL SCREWDRIVER AND WHEN THE SCREWDRIVER WAS REMOVED FROM THE SCREW THE TULIP HEAD POPPED OFF THE SCREW. AT THIS TIME A NEW K-WIRE WAS INSERTED AND THE BONE SCREW WAS BACKED OUT OF THE PEDICLE. ANOTHER SCREW AND TULIP WERE ASSEMBLED AND IMPLANTED WITH NO FURTHER ISSUE. THERE WAS A FIVE (5) MINUTE DELAY TO THE PROCEDURE DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16949974 ↗