Reform Pedicle Screw System HXX-39-0001Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00840019928809), received between Jan 8, 2020 and Apr 14, 2023 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2023Fracture; Fracture

  IT WAS REPORTED THAT A LUMBAR FIXATION PROCEDURE WAS PERFORMED ON (B)(6), 2023, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. THE BONE WAS PREPARED WITH A 5.5MM TAP AND WHILE INSERTING A 6MM REDUCTION SCREW, THE TIP OF THE REFORM DRIVER WITH MECHANICAL LOCK (HXX-39-0001) BROKE. THE BROKEN TIP PIECE WAS REMOVED FROM THE HEAD OF THE SCREW AND THE PROCEDURE WAS COMPLETED UTILIZING ANOTHER DRIVER READILY AVAILABLE IN THE SET. THERE WAS NO PATIENT INJURY OR DELAY TO THE PROCEDURE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16744994 ↗
• MalfunctionJun 1, 2022Break

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2022, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. DURING ATTEMPTED SCREW INSERTION THE TIP OF THE REFORM DRIVER WITH MECHANICAL LOCK (HXX-39-0001) BROKE. THE TIP WAS REMOVED FROM THE HEAD OF THE SCREW AND THE PROCEDURE WAS COMPLETED UTILIZING THE SECOND DRIVER READILY AVAILABLE IN THE SET. THERE WAS A 5-10 MINUTE DELAY TO THE PROCEDURE FROM REMOVING THE BROKEN TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14567948 ↗
• MalfunctionMar 10, 2022Break

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED IN (B)(6) ON (B)(6) 2022, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. DURING THE PLACEMENT OF THE FIRST ILIAC SCREW, THE DOCTOR NOTED SOME RESISTANCE OF THE 80MM SCREW GOING INTO THE BONE WHEN THE TIP OF THE T20, POLYAXIAL DRIVER, REFORM DEGEN (39-SP-0700) BROKE. THE DOCTOR THEN ATTEMPTED TO REMOVE THE SCREW IN ORDER TO PLACE A SMALLER 70MM ONE WHEN THE TIP OF A SECOND REFORM DRIVER WITH MECHANICAL LOCK (HXX-39-0001) BROKE. THE PROCEDURE WAS THEN COMPLETED UTILIZING ANOTHER DRIVER READILY AVAILABLE. THERE WAS A TEN MINUTE DELAY TO THE PROCEDURE DUE TO THE REPORTED MALFUNCTIONS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13720717 ↗
• InjuryAug 9, 2021Detachment of Device or Device Component

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2021, USING THE REFORM PEDICLE SCREW SYSTEM. WHEN THE DOCTOR WAS ATTEMPTING TO BACK OUT A SCREW THAT HE HAD JUST IMPLANTED, THE TIP OF THE REFORM DRIVER WITH MECHANICAL LOCK (HXX-39-0001) BROKE OFF. THE TIP WAS UNABLE TO BE REMOVED AND REMAINS IMPLANTED IN THE HEAD OF THE SCREW. THE SECOND DRIVER, READILY AVAILABLE IN THE SET, WAS USED TO COMPLETE THE PROCEDURE WITH NO DELAY.

  Patient problems: Insufficient Information

  MAUDE report 12297291 ↗
• InjuryMay 24, 2021Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A REVISION PLIF WAS PERFORMED, ON (B)(6) 2021, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. DURING THE PROCEDURE, A REFORM MODULAR 6.5 X 40MM POLYAXIAL BONE SCREW (39-MS-6540) WAS REMOVED, THE HOLE WAS THEN TAPPED WITH THE 65MM& 75MM TAPS AND UPON INSERTION OF A REDUCTION POLYAXIAL SCREW ASSEMBLY - Æ7.5MM X 50MM (39-RP-7550), DRIVING WITH POWER, THE TIP OF THE REFORM DRIVER WITH MECHANICAL LOCK (HXX-39-0001) BROKE. THE SCREW WAS HELICOPTERED OUT AND REPLACED. SUBSEQUENTLY, ANOTHER LEVEL WAS PREPPED USING THE 65MM, 75MM & 85MM TAPS IN SEQUENCE AND UPON INSERTION OF A REFORM 8.5 X 110MM POLYAXIAL PEDICLE SCREW (39-PA-8511), THE TIP OF A SECOND REFORM DRIVER WITH MECHANICAL LOCK (HXX-39-0001) BROKE. THIS FAILURE OCCURRED BEFORE THE SCREW WAS FULLY SEATED. THE SCREW WAS HELICOPTERED OUT AND REPLACED WITH A REFORM 8.5 X 100MM POLYAXIAL PEDICLE SCREW (39-PA-8500), UTILIZING A DRIVER THAT WAS READILY AVAILABLE IN ANOTHER REFORM SET. THERE WAS NO PATIENT INJURY, BUT THERE WAS A DELAY OF FIVE (5) MINUTES BECAUSE OF THE REPORTED MALFUNCTIONS. INITIAL IMPLANTATION WAS TWO-YEARS AGO. REVISION WAS REQUIRED TO ADD MORE STABILITY AND EXTEND THE CONSTRUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11870891 ↗
• InjuryMay 24, 2021Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A REVISION PLIF WAS PERFORMED, ON (B)(6) 2021, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. DURING THE PROCEDURE, A REFORM MODULAR 6.5 X 40MM POLYAXIAL BONE SCREW (39-MS-6540) WAS REMOVED, THE HOLE WAS THEN TAPPED WITH THE 65MM& 75MM TAPS AND UPON INSERTION OF A REDUCTION POLYAXIAL SCREW ASSEMBLY - Æ7.5MM X 50MM (39-RP-7550), DRIVING WITH POWER, THE TIP OF THE REFORM DRIVER WITH MECHANICAL LOCK (HXX-39-0001) BROKE. THE SCREW WAS HELICOPTERED OUT AND REPLACED. SUBSEQUENTLY, ANOTHER LEVEL WAS PREPPED USING THE 65MM, 75MM & 85MM TAPS IN SEQUENCE AND UPON INSERTION OF A REFORM 8.5 X 110MM POLYAXIAL PEDICLE SCREW (39-PA-8511), THE TIP OF A SECOND REFORM DRIVER WITH MECHANICAL LOCK (HXX-39-0001) BROKE. THIS FAILURE OCCURRED BEFORE THE SCREW WAS FULLY SEATED. THE SCREW WAS HELICOPTERED OUT AND REPLACED WITH A REFORM 8.5 X 100MM POLYAXIAL PEDICLE SCREW (39-PA-8500), UTILIZING A DRIVER THAT WAS READILY AVAILABLE IN ANOTHER REFORM SET. THERE WAS NO PATIENT INJURY, BUT THERE WAS A DELAY OF FIVE (5) MINUTES BECAUSE OF THE REPORTED MALFUNCTIONS. INITIAL IMPLANTATION WAS TWO-YEARS AGO. REVISION WAS REQUIRED TO ADD MORE STABILITY AND EXTEND THE CONSTRUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11870884 ↗
• MalfunctionJun 3, 2020Break

  IT WAS REPORTED THAT A POSTERIOR LUMBAR PROCEDURE WAS PERFORMED ON (B)(6) 2020, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. A 39-PA-7535 7.5 X 35MM REFORM PEDICLE SCREW WAS IMPLANTED, SUBSEQUENTLY THE SURGEON DECIDED TO REPOSITION THE SCREW TO ALLOW ROOM FOR AN SI FUSION. WHEN ATTEMPTING TO REMOVE THE SCREW THE TIP OF A REFORM DRIVER BROKE. A ROD WAS IMMEDIATELY USED TO REMOVE THE SCREW AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED UTILIZING THE SECOND DRIVER READILY AVAILABLE IN THE SET. THERE WAS NO PATIENT INJURY OR SIGNIFICANT DELAY TO THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10116657 ↗
• MalfunctionMay 13, 2020Break

  IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020, TO EXTEND THE EXISTING CONSTRUCT. WHILE ATTEMPTING TO REMOVE ONE OF THE REFORM PEDICLE SCREWS, HA COATED, THE TIP OF THE REFORM DRIVER WITH MECHANICAL LOCK (HXX-39-0001) BROKE. THE SURGEON THEN USED THE HELICOPTER METHOD TO SUCCESSFULLY REMOVE THE SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED UTILIZING THE SECOND DRIVER READILY AVAILABLE IN THE SET. THERE WAS NO PATIENT INJURY OR DELAY TO THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10051755 ↗
• MalfunctionJan 8, 2020Break

  INFORMATION RECEIVED FROM THE DISTRIBUTOR INDICATES THAT A PROCEDURE WAS PERFORMED BY ON (B)(6) 2019, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. UPON ATTEMPTED INSERTION OF A SCREW THE TIP OF A REFORM DRIVER WITH MECHANICAL LOCK (HXX-39-0001) BROKE. THE TIP WAS REMOVED AND THE PROCEDURE WAS COMPLETED UTILIZING ANOTHER DRIVER READILY AVAILABLE IN THE SET. THERE WAS NO PATIENT INJURY OR DELAY TO THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9565481 ↗