Reform Ti Modular 39-MT-0401Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840019932622), received between Aug 17, 2023 and Jul 8, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• InjuryJul 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED IN AUSTRALIA ON (B)(6) 2024, UTILIZING THE REFORM MC MIDLINE CORTICAL SCREW SYSTEM. DURING THE PROCEDURE THE REFORM TI MODULAR POLYAXIAL TULIP ASSEMBLY (39-MT-0401) WAS ASSEMBLED ONTO THE MIDLINE CORTICAL BONE SCREW (59-BP-XXXX) ON THE NURSES TABLE. THE ASSEMBLED SCREW WAS LOADED ONTO A T25 CANNULATED POLY DRIVER W/LOCK (C3164) AND THE DRIVER WAS TIGHTENED AND LOCKED. THE SCREW WAS PLACED INTO THE PATIENT AND WHEN THE SCREWDRIVER WAS RELEASED FROM THE SCREW THE TULIP DISASSEMBLED FROM THE SCREW AND DROPPED INTO THE WOUND. THE TULIP WAS RETRIEVED USING FORCEPS AND WAS SNAPPED BACK ONTO THE SCREW BY THE SURGEON AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY AND AN APPROXIMATE 5 MINUTE DELAY TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19689225 ↗
• InjuryJun 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED IN AUSTRALIA ON (B)(6) 2024, UTILIZING THE REFORM MC MIDLINE CORTICAL SCREW SYSTEM. WHILE INSERTING A REFORM TI MODULAR POLYAXIAL TULIP ASSEMBLY (39-MT-0401) ASSEMBLED ON A Ø6.5 X 45MM MIDLINE CORTICAL BONE SCREW (59-BP-6545) THE TULIP CAME OFF OF THE SCREW WHEN THE DRIVER WAS REMOVED. THE TULIP DROPPED INTO THE WOUND AND WAS RETRIEVED USING FORCEPS. THE TULIP WAS THEN SNAPPED BACK ONTO THE SCREW SHANK AND THE PROCEDURE WAS COMPLETED WITH ONLY A SHORT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19608580 ↗
• MalfunctionAug 17, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED BY ON (B)(6)2023, UTILIZING THE REFORM TI MODULAR SCREW SYSTEM. THE SCRUB TECH CONNECTED THE REFORM TI MODULAR POLYAXIAL TULIP ASSEMBLY (39-MT-0401) TO THE 65MM REFORM TI MODULAR NON-CANNULATED SCREW (39-SB-XXXX), LOADED THE ASSEMBLED SCREW/TULIP ON THE DRIVER AND HANDED IT TO THE SURGEON. WHEN THE SURGEON ATTEMPTED TO IMPLANT THE SCREW, THE TULIP DETACHED FROM THE SCREW. THE SCREW WAS TAKEN TO THE BACK TABLE AND REASSEMBLED ON A DIFFERENT SCREW AND SUBSEQUENTLY IMPLANTED SUCCESSFULLY. THERE WAS NO DELAY TO THE PROCEDURE OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17568836 ↗