Reform Ti HA Coated Pedicle Screw 39-HT-7535Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815362029190), received between Oct 25, 2021 and Oct 25, 2021 — 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.

• InjuryOct 25, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2021, IN WHICH REFORM TI PEDICLE SCREW SYSTEM PRODUCT WAS IMPLANTED. SUBSEQUENTLY, IT WAS IDENTIFIED THAT AT LEAST ONE OF THE PEDICLE SCREWS WAS NOTED TO BE LOOSE AND A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2021, IN WHICH THREE (3) OF THE (4) SCREWS IMPLANTED WERE REMOVE AND REPLACED WITH A COMPETITOR'S SCREWS. DURING THE REVISION PROCEDURE WHEN ATTEMPTING TO REMOVE ONE OF THE PREVIOUSLY TORQUED LOCK SCREWS, THE TIP OF THE LOCK-SCREW TORQUE DRIVER (39-RD-0060) BROKE OFF. THE TIP WAS REMOVED, AND THE PROCEDURE SUCCESSFULLY COMPLETED UTILIZING THE SECOND DRIVER, READILY AVAILABLE IN THE SET. SCREWS REMOVED WERE DISCARDED AT THE HOSPITAL. AS IT IS UNKNOWN WHICH OF THE THREE SCREWS REMOVED WERE LOOSE, ALL THREE ARE BEING REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12691192 ↗
• InjuryOct 25, 2021Break; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2021, IN WHICH REFORM TI PEDICLE SCREW SYSTEM PRODUCT WAS IMPLANTED. SUBSEQUENTLY, IT WAS IDENTIFIED THAT AT LEAST ONE OF THE PEDICLE SCREWS WAS NOTED TO BE LOOSE AND A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2021, IN WHICH THREE (3) OF THE (4) SCREWS IMPLANTED WERE REMOVE AND REPLACED WITH A COMPETITOR'S SCREWS. DURING THE REVISION PROCEDURE WHEN ATTEMPTING TO REMOVE ONE OF THE PREVIOUSLY TORQUED LOCK SCREWS, THE TIP OF THE LOCK-SCREW TORQUE DRIVER (39-RD-0060) BROKE OFF. THE TIP WAS REMOVED, AND THE PROCEDURE SUCCESSFULLY COMPLETED UTILIZING THE SECOND DRIVER, READILY AVAILABLE IN THE SET. SCREWS REMOVED WERE DISCARDED AT THE HOSPITAL. AS IT IS UNKNOWN WHICH OF THE THREE SCREWS REMOVED WERE LOOSE, ALL THREE ARE BEING REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12691190 ↗
• MalfunctionOct 25, 2021Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2021, IN WHICH REFORM TI PEDICLE SCREW SYSTEM PRODUCT WAS IMPLANTED. SUBSEQUENTLY, IT WAS IDENTIFIED THAT AT LEAST ONE OF THE PEDICLE SCREWS WAS NOTED TO BE LOOSE AND A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2021, IN WHICH THREE (3) OF THE (4) SCREWS IMPLANTED WERE REMOVE AND REPLACED WITH A COMPETITOR'S SCREWS. DURING THE REVISION PROCEDURE WHEN ATTEMPTING TO REMOVE ONE OF THE PREVIOUSLY TORQUED LOCK SCREWS, THE TIP OF THE LOCK-SCREW TORQUE DRIVER (39-RD-0060) BROKE OFF. THE TIP WAS REMOVED, AND THE PROCEDURE SUCCESSFULLY COMPLETED UTILIZING THE SECOND DRIVER, READILY AVAILABLE IN THE SET. SCREWS REMOVED WERE DISCARDED AT THE HOSPITAL. AS IT IS UNKNOWN WHICH OF THE THREE SCREWS REMOVED WERE LOOSE, ALL THREE ARE BEING REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12691129 ↗