Reform Pedicle Screw System 39-SP-0700Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00840019928731), received between Oct 17, 2019 and Mar 28, 2024 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2024Fracture; Fracture

  IT WAS REPORTED THAT A REVISION PROCEDURE TO EXTEND AN EXISTING CONSTRUCT WAS PERFORMED ON AN UNKNOWN DATE, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. WHILE REMOVING A PREVIOUSLY IMPLANTED SCREW, THE TIP OF THE T20, POLYAXIAL DRIVER, REFORM DEGEN (39-SP-0700) BROKE. THE TIP WAS REMOVED AND THE PROCEDURE WAS COMPETED UTILIZING OTHER INSTRUMENTATION READILY AVAILABLE IN THE SET. THERE WAS NO PATIENT INJURY OR DELAY TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18996749 ↗
• InjuryOct 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2023, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. WHILE REMOVING A 7.5MM SCREW FROM S1 ON THE PATIENT'S LEFT SIDE, THE T20, POLYAXIAL DRIVER, REFORM DEGEN (39-SP-0700) TIP BROKE. THE DRIVER WAS NOT SCREWED DOWN AND ENGAGED WITH THE SCREW WHEN THE BREAKAGE OCCURRED. SUBSEQUENTLY, WE CUT A ROD FROM THE PATIENT THAT HAD BEEN REMOVED FROM THE RIGHT SIDE ALREADY. SURGEON THEN PLACED THE ROD INTO THE S1 SCREW ON THE LEFT AND TORQUED IT DOWN. THE PA, THEN USED THE COUNTER TORQUE TO SPIN THE SCREW COUNTERCLOCKWISE AND REMOVE USING THE "HELICOPTER" METHOD. THERE WAS NO PATIENT INJURY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18032341 ↗
• InjuryNov 14, 2022Break

  IT WAS REPORTED THAT A PROCEDURE WAS ON (B)(6) 2022, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. UPON ATTEMPTED INSERTION OF ONE OF THE POLYAXIAL SCREWS THE TIP OF THE T20, POLYAXIAL DRIVER, REFORM DEGEN (39-SP-0700) BROKE. THE BROKEN TIP WAS LEFT IN THE HEAD OF THE SCREW, IMPLANTED IN THE PATIENT. THE ROD WAS ASSEMBLED OVER THE SCREW WITH NO ISSUE. THE DOCTOR INDICATED THAT HE HAS TO USE EXCESSIVE FORCE WHILE INSERTING THE SCREW. THERE WAS NO PATIENT INJURY OR DELAY TO THE PROCEDURE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15793085 ↗
• MalfunctionMar 10, 2022Break; Physical Resistance/Sticking

  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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13720709 ↗
• InjuryOct 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 INSERTION OF A 6.5 X 45MM REFORM PEDICLE SCREW, THE TIP OF THE POLYAXIAL DRIVER (39-SP-0700) BROKE OFF IN THE HEAD OF THE SCREW. THE TIP COULD NOT BE REMOVED AND REMAINS IN THE HEAD OF THE SCREW IMPLANTED IN THE PATIENT. A ROD WAS ABLE TO BE ASSEMBLED IN THE TULIP TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO DELAY OR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10637443 ↗
• 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 SPECIFIC INFORMATION REGARDING HOW THE TIP BROKE HAVE BEEN UNSUCCESSFUL. NO PATIENT OR PROCEDURE ISSUES HAVE BEEN REPORTED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10488598 ↗
• MalfunctionSep 3, 2020Break

  NOTIFICATION RECEIVED FROM THE QUALITY TECH INDICATES THAT THE POLYAXIAL DRIVER (39-SP-0700) WAS RETURNED WITH A BROKEN TIP. ATTEMPTS TO OBTAIN SPECIFIC INFORMATION REGARDING HOW THE TIP BROKE HAVE BEEN UNSUCCESSFUL. NO PATIENT OR PROCEDURE ISSUES HAVE BEEN REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10488596 ↗
• InjuryMar 10, 2020Break

  IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED TO EXTEND AND EXISTING CONSTRUCT ON (B)(6) 2020, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. AFTER TAPPING THE BONE USING THE 6.5MM & 7.5MM TAPS A 7.5 X 55MM REFORM PEDICLE SCREW WAS BEING PLACED WHEN THE TIP OF THE POLYAXIAL DRIVER (39-SP-0700) BROKE. THE SCREW WAS FULLY SEATED AND THE BROKEN TIP OF THE DRIVER WAS LEFT IN THE HEAD OF THE SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED UTILIZING THE SECOND DRIVER READILY AVAILABLE IN THE SET WITH NO DELAY.

  Patient problems: No Code Available

  MAUDE report 9812097 ↗
• MalfunctionOct 24, 2019Break

  IT WAS REPORTED THAT A 2-LEVEL PLIF PROCEDURE WAS PERFORMED BY ON (B)(6) 2019, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. UPON IMPLANTATION OF A REFORM PEDICLE SCREW THE TIP OF THE REFORM POLYAXIAL DRIVER (39-SP-0700) BROKE. THE TIP WAS REMOVED AND THE PROCEDURE WAS COMPLETED UTILIZING ANOTHER DRIVER READILY AVAILABLE IN THE SET. THERE WAS NO SIGNIFICANT DELAY TO THE PROCEDURE OR PATIENT INJURY AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9235121 ↗
• MalfunctionOct 17, 2019Break

  IT WAS REPORTED THAT DURING A FUSION PROCEDURE PERFORMED IN (B)(6) ON OR AROUND (B)(6) 2019, UTILIZING THE REFORM PEDICLE SCREW SYSTEM, THE TIP OF THE REFORM POLYAXIAL DRIVER (39-SP-0700) BROKE WHILE INSERTING 7.5MM REFORM PEDICLE SCREW. THE TIP OF THE DRIVER WAS EASILY REMOVED AND THE PROCEDURE COMPLETED UTILIZING ANOTHER DRIVER READILY AVAILABLE IN THE SET, WITH NO PATIENT INJURY AND A ONE MINUTE DELAY. INFORMATION PROVIDED INDICATES THAT THE PATIENT HAD PARTICULARLY HARD BONE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9202547 ↗