Reform Pedicle Screw System 39-SP-0601Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00840019928700), received between Mar 9, 2020 and Jul 10, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT A TLIF L4-5 WITH BL SCREW PLACEMENT WAS PERFORMED ON (B)(6) 2023, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. INCISION MADE, EXPOURE, BURR, 3.2MM DRILL INTO PEDICLE, 6.5MM PRECISION TAP, 6/5 X 40MM HT SCREWS WITH 45MM LT ROD AND LOCK SCREWS (X2) WERE PLACED, WITHOUT FINAL TIGHTENING OF LOCK SCREWS. THE SECOND ROD AND LOCK SCREWS WERE THEN PLACED UTILIZING THE T20, RETENTION BONE-SCREW DRIVER, REFORM (39-SP-0601), COUNTER TORQUE WRENCH AND THE OFFSET RATCHETING TORQUE HANDLE WAS USED SUCCESSFULLY ON TWO (2) SCREWS. WHEN ATTEMPTING TO FINAL TIGHTEN THE LEFT L5 LOCK SCREW THE TIP OF THE DRIVER BROKE. THE BROKEN TIP WAS REMOVED FROM THE LOCK SCREW AND THE SECOND DRIVER, READILY AVAILABLE IN THE SET, WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. X-RAYS WERE PERFORMED TO VERIFY NO FRAGMENTS REMAINED IN THE PATIENT. THERE WAS NO PATIENT INJURY OR DELAY TO THE PROCEDURE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17289249 ↗
• MalfunctionJan 3, 2022Break

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED IN (B)(6), ON (B)(6) 2021, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. WHILE TIGHTENING A LOCK SCREW, THREE LOCK-SCREW TORQUE DRIVERS (39-RD-0060) BROKE. THE TIPS WERE ALL REMOVED, AND THE LOCK SCREW WAS SUCCESSFULLY TIGHTENED USING ANOTHER DRIVER, READILY AVAILABLE, WITH THE TORQUE LIMITING HANDLE. THERE WAS NO INJURY TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13142576 ↗
• MalfunctionNov 11, 2021Break

  IT WAS REPORTED THAT A THREE-LEVEL PROCEDURE WAS PERFORMED IN (B)(6) ON (B)(6) 2021, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. WHILE THE SURGEON WAS LOCKING THE LOCK SCREW THE TIPS OF TWO LOCK-SCREW TORQUE DRIVERS (39-RD-0060) BROKE. THE TIP OF A T20, RETENTION BONE-SCREW DRIVER, REFORM (39-SP-0601) ALSO BROKE. ALL BROKEN TIPS WERE REMOVED AND ALL LOCK SCREWS WERE SUCCESSFULLY TIGHTENED USING THE TORQUE LIMITING HANDLE. THERE WAS NO PATIENT INJURY OR DELAY TO THE PROCEDURE RESULTING FROM THESE FAILURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12796741 ↗
• MalfunctionSep 7, 2021Break

  IT WAS REPORTED THAT THE TIP OF THE RETENTION BONE-SCREW DRIVER (39-SP-0601) BROKE DURING A REMOVAL CASE PERFORMED ON (B)(6) 2021. NO ADDITIONAL DETAILS WERE PROVIDED. THERE WAS NO PATIENT INJURY OR SIGNIFICANT DELAY TO THE PROCEDURE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12433599 ↗
• MalfunctionOct 6, 2020Break

  IT WAS REPORTED THAT A REVISION LUMBAR FUSION PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE, UTILIZING THE REFORM PEDICLE SCREW SYSTEM, TO EXTEND AN EXISTING CONSTRUCT. UPON ATTEMPTED REMOVAL OF EXISTING HARDWARE THE TIP OF THE RETENTION BONE SCREW DRIVER (39-SP-0601) BROKE OFF IN THE HEAD OF THE SCREW. THE TIP WAS REMOVED AND THE SCREW WAS REMOVED SUCCESSFULLY AND THE PROCEDURE PROCEEDED WITHOUT SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10637469 ↗
• MalfunctionSep 3, 2020Break

  NOTIFICATION RECEIVED FROM THE QUALITY TECH INDICATES THAT THE RETENTION BONE-SCREW DRIVER (39-SP-0601) WAS RETURNED WITH A BROKEN TIP. ATTEMPTS TO OBTAIN DETAILS OF HOW THE TIP BROKE HAVE BEEN UNSUCCESSFUL. NO PATIENT OR PROCEDURE ISSUE HAVE BEEN REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10489748 ↗
• MalfunctionMar 9, 2020Break; Difficult to Remove; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A REVISION POSTERIOR LUMBAR FUSION PROCEDURE WAS PERFORMED ON (B)(6) 2020, UTILIZING THE REFORM PEDICAL SCREW SYSTEM. UPON ATTEMPTED REMOVAL OF A 6.5 X 40MM REFORM PEDICLE SCREW (NOT HA COATED), THAT WAS ORIGINALLY IMPLANTED ON (B)(6) 2018, THE TIP OF THE RETENTION BONE-SCREW DRIVER (39-SP-0601) BROKE AND COULD NOT BE REMOVED FROM THE HEAD OF THE SCREW. THE DOCTOR THEN "HELICOPTERED" THE SCREW OUT AND WAS ABLE TO SUCCESSFULLY REPLACE WITH A NEW SCREW. THIS RESULTED IN A TEN (10) MINUTE DELAY TO THE PROCEDURE. THE REVISION WAS PERFORMED DUE TO DEGENERATION AROUND THE PREVIOUS FUSION, NOT TO FAILURE OF PRECISION SPINE PRODUCT.

  Patient problems: Tissue Damage

  MAUDE report 9805502 ↗