Reform Ti CT Modular MIS Pedicle Screw System 64-MT-0403Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00840019940610), received between Jul 18, 2022 and Jun 29, 2026 — classified as 9 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED IN AUSTRALIA ON (B)(6) 2026, UTILIZING THE REFORM TI MODULAR SYSTEM, 59-BP-XXXX SERIES SCREWS WITH THE REFORM TI MODULAR POLYAXIAL TULIP ASSEMBLY (39-MT-0401). THE TULIP AND THE SHANK WERE SECURELY ASSEMBLED BY THE NURSE AND CHECKED THAT THEY WERE SECURE. SCREW WAS ASSEMBLED ONTO A NAVIGATED/ASSEMBLED SCREWDRIVER. SURGEON PLACED THE SCREW IN THE PEDICLE AND UPON REMOVING THE SCREWDRIVER, THE TULIP FELL OFF AND INTO THE SURGICAL SITE. IT WAS RECOVERED AND RE-ASSEMBLED ONTO THE SHANK IN-SITU. THE REST OF THE SURGERY PROCEEDED AS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25659934 ↗
• InjuryJun 22, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2026, IN AUSTRALIA, UTILIZING THE REFORM CT PEDICLE SCREW SYSTEM. THE MODULAR POLYAXIAL TULIP ASSEMBLY REFORM MIS PEDICLE SCREW SYSTEM (64-MT-0403) WAS ASSEMBLED ON A 5-BP-XXXX SERIES SCREW BY THE NURSE AND CHECKED THAT IT WAS SECURE. THE SCREW WAS THEN ASSEMBLED ONTO A NAVIGATED/ASSEMBLED SCREWDRIVER. THE SURGEON PLACED THE SCREW IN THE PEDICLE AND UPON REMOVING THE SCREWDRIVER, THE TULIP FELL OFF AND INTO THE SURGICAL SITE. IT WAS RECOVERED AND REASSEMBLED, WITH A BIT OF DIFFICULTY, TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25585273 ↗
• MalfunctionMar 30, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED UTILIZING THE REFORM MODULAR PEDICLE SCREW SYSTEM. DURING THE PROCEDURE THE MODULAR POLYAXIAL TULIP ASSEMBLY REFORM MIS PEDICLE SCREW SYS (64-MT-0403) POPPED OFF OF THE SCREW. ATTEMPTS TO OBTAIN ADDITIONAL DETAILS HAVE BEEN UNSUCCESSFUL TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24719836 ↗
• InjuryMar 16, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2026. DURING PLACEMENT OF A 7.5 X 40MM MODULAR SCREW (39-SK-7540) WITH AN ATTACHED CT TULIP (64-MT-0403), THE ATTENDANT COMMENTED THAT ALTHOUGH SHE WAS TURNING THE SCREWDRIVER (75-RT-1750), SHE DID NOT FEEL/OBSERVE ADVANCEMENT. IT WAS THEN THAT THE PRECISION SPINE ENGINEER LOOKED AT THE POSITION OF THE ASSISTANT'S HANDS AND NOTED THEIR LEFT HAND WAS CONTACTING THE KNOB ON THE SCREWDRIVER THAT IS USED TO ATTACH/DETACH THE SCREWDRIVER FROM THE IMPLANT. FROM THIS IT WAS SURMISED THAT THIS MAY HAVE CAUSED THE SCREW TO LOOSEN FROM THE DRIVER, AND HE MADE HER AWARE AS SUCH. SHE THEN REMOVED THE SCREW AND DRIVER FROM THE PATIENT AND CONFIRMED THAT THIS WAS THE CASE. THE IMPLANT WAS THEN RE-TIGHTENED TO THE SCREWDRIVER BEFORE PROCEEDING TO RE-INSERT INTO THE S1 PEDICLE. SOON AFTERWARDS, IT WAS COMMENTED FROM EITHER THE SURGEON OR THE ASSISTANT THAT SOMETHING DID NOT FEEL RIGHT WITH THE RE-INSERTION OF THE SCREW IMPLANT. THE DRIVER WAS AGAIN REMOVED FROM THE PATIENT, THIS TIME ONLY THE TULIP WAS ATTACHED TO THE DRIVER; THE BONE SCREW REMAINED IN THE PATIENT. A SERIES OF FLUOROSCOPIC IMAGES WAS TAKEN TO LOCATE THE POSITION OF THE MISSI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24612136 ↗
• InjuryFeb 24, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2026. DURING PLACEMENT OF A 7.5 X 40MM MODULAR SCREW (39-SK-7540) WITH AN ATTACHED CT TULIP (64-MT-0403), THE ATTENDANT COMMENTED THAT ALTHOUGH SHE WAS TURNING THE SCREWDRIVER (75-RT-1750), SHE DID NOT FEEL/OBSERVE ADVANCEMENT. IT WAS THEN THAT THE PRECISION SPINE ENGINEER LOOKED AT THE POSITION OF THE ASSISTANT'S HANDS AND NOTED THEIR LEFT HAND WAS CONTACTING THE KNOB ON THE SCREWDRIVER THAT IS USED TO ATTACH/DETACH THE SCREWDRIVER FROM THE IMPLANT. FROM THIS IT WAS SURMISED THAT THIS MAY HAVE CAUSED THE SCREW TO LOOSEN FROM THE DRIVER, AND HE MADE HER AWARE AS SUCH. SHE THEN REMOVED THE SCREW AND DRIVER FROM THE PATIENT AND CONFIRMED THAT THIS WAS THE CASE. THE IMPLANT WAS THEN RE-TIGHTENED TO THE SCREWDRIVER BEFORE PROCEEDING TO RE-INSERT INTO THE S1 PEDICLE. SOON AFTERWARDS, IT WAS COMMENTED FROM EITHER THE SURGEON OR THE ASSISTANT THAT SOMETHING DID NOT FEEL RIGHT WITH THE RE-INSERTION OF THE SCREW IMPLANT. THE DRIVER WAS AGAIN REMOVED FROM THE PATIENT, THIS TIME ONLY THE TULIP WAS ATTACHED TO THE DRIVER; THE BONE SCREW REMAINED IN THE PATIENT. A SERIES OF FLUOROSCOPIC IMAGES WAS TAKEN TO LOCATE THE POSITION OF THE MISSI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434966 ↗
• MalfunctionDec 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A ONE LEVEL REFORM CT CASE AT L4-5 WAS PERFORMED ON AN UNKNOWN DATE. THE RIGHT L4 CT TULIP DISENGAGED WHILE SET SCREW WAS BEING PLACED. TULIP WAS REENGAGED USING THE TAB BREAKER, ROD AND SET SCREW WERE PLACED IN STANDARD FASHION. I MONITORED THE SCRUB TECH ASSEMBLE THE RIGHT-SIDE SCREWS TO CONFIRM THEY WERE SNAPPED TOGETHER PROPERLY. AFTER INSERTION, LEFT SIDE L4 TULIP DISENGAGED PRIOR TO ROD INSERTION. THE TULIP WAS REPLACED, AND THE PRIOR ONE WAS SET ASIDE FOR INSPECTION. THERE WAS NO PATIENT INJURY BUT A DELAY OF 15 MINUTES TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20942474 ↗
• MalfunctionOct 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2024, UTILIZING THE REFORM MIS PEDICLE SCREW SYSTEM. THE MODULAR POLYAXIAL TULIP ASSEMBLY REFORM MIS PEDICLE SCREW SYS (64-MT-0403) WAS BEING LOADED ONTO THE SCREW SHANK OUTSIDE OF THE CADDY USING AXIAL FORCE TO CONNECT THE TWO PARTS. A CLICK WAS HEARD, AND THE SCRUB TECH THEN TESTED THE CONNECTION BY PULLING THE SCREW SHANK AND GOLD TULIP IN OPPOSITE DIRECTIONS PER THE INSTRUCTIONS IN THE SURGICAL TECHNIQUE GUIDE. AS THE SCREW WAS ADVANCED INTO THE PEDICLE, THE TULIP POPPED OFF OF THE SCREW SHANK AND REMAINED THREADED ONTO THE DRIVER AS THE TULIP HIT THE FACET. THE SCREW SHANK WAS BACKED OUT OF THE BONE A COUPLE OF TURNS AND A DIFFERENT GOLD TULIP WAS PUSHED ONTO THE SHANK BEFORE IT WAS PUT BACK INTO POSITION. WE WERE ABLE TO FINISH THE CASE WITHOUT ANY FURTHER INCIDENT. THERE WAS NO PATIENT INJURY BUT A LESS THAN FIVE (5) MINUTE DELAY TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20355411 ↗
• MalfunctionOct 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2024, UTILIZING THE REFORM MIS PEDICLE SCREW SYSTEM. THE MODULAR POLYAXIAL TULIP ASSEMBLY REFORM MIS PEDICLE SCREW SYS (64-MT-0403) WAS BEING LOADED ONTO THE SCREW SHANK OUTSIDE OF THE CADDY USING AXIAL FORCE TO CONNECT THE TWO PARTS. A CLICK WAS HEARD, AND THE SCRUB TECH THEN TESTED THE CONNECTION BY PULLING THE SCREW SHANK AND GOLD TULIP IN OPPOSITE DIRECTIONS PER THE INSTRUCTIONS IN THE SURGICAL TECHNIQUE GUIDE. AS THE SCREW WAS ADVANCED INTO THE PEDICLE, THE TULIP POPPED OFF OF THE SCREW SHANK AND REMAINED THREADED ONTO THE DRIVER AS THE TULIP HIT THE FACET. THE SCREW SHANK WAS BACKED OUT OF THE BONE A COUPLE OF TURNS AND A DIFFERENT GOLD TULIP WAS PUSHED ONTO THE SHANK BEFORE IT WAS PUT BACK INTO POSITION. WE WERE ABLE TO FINISH THE CASE WITHOUT ANY FURTHER INCIDENT. THERE WAS NO PATIENT INJURY REPORTED BUT A FIVE (5) MINUTE DELAY TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20355332 ↗
• MalfunctionJul 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 TI MIS CT SCREW SYSTEM. THE MODULAR POLYAXIAL TULIP ASSEMBLY REFORM MIS PEDICLE SCREW SYS (64-MT-0403) WAS ASSEMBLED TO A 59-BC-XXXX MIDLINE CORTICAL BONE SCREW, CANNULATED AND BEING INSERTED WITH A STANDARD NAVIGATED REFORM CT SCREWDRIVER THE TULIP DISASSEMBLED FROM THE SCREW. IT WAS THEN SNAPPED BACK ONTO THE SCREW AND SUCCESSFULLY IMPLANTED. THERE WAS NO PATIENT INJURY REPORTED BUT THERE WAS A FIVE (5) MINUTE DELAY TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19690119 ↗
• InjuryAug 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN L5-S1 CT MIS PROCEDURE WAS PERFORMED ON (B)(6) 2023, UTILIZING THE REFORM CT MIS PEDICLE SCREW SYSTEM. DURING THE PROCEDURE FOUR (4) Ø6.5MM X 40MM REFORM TI MODULAR CANNULATED SCREWS (39-SK-6540) WERE REMOVED FROM THE CADDY AND THE MODULAR POLYAXIAL TULIP ASSEMBLY REFORM MIS PEDICLE SCREW SYSTEM (64-MT-0403) WAS SNAPPED ON BY HAND. THEY WERE THEN GIVEN THE SLIGHTEST TUG. THE SURGEON PLACED THE SCREWS ON THE LEFT SIDE, ALLOWING THE PA TO PLACE THE RIGHT SIDE SCREWS. ON THE FIRST SCREW AT L5 ON THE LEFT SIDE THE TULIP DISASSEMBLED. THE SCREW WAS REMOVED WITH THE HEIGHT ADJUSTER AND NEW SCREW AND TULIP READILY AVAILABLE IN THE SET WERE PLACED WITH NO FURTHER ISSUE. THERE WAS NO PATIENT INJURY WITH A SLIGHT DELAY OF 3-5 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17624860 ↗
• InjuryJul 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2023, BY DR. (B)(6), UTILIZING THE REFORM TI MODULAR PEDICLE SCREW SYSTEM. THE SCRUB TECH ASSEMBLED THE Ø6.5MM X 40MM REFORM TI MODULAR CANNULATED SCREW (39-SK-6540) AND THE REFORM TI MODULAR TOWER TULIP (39-MT-0403) ON THE BACK TABLE. FOLLOWING ASSEMBLY, SHE PUSHED AND PULLED ON THE TULIP PRIOR TO LOADING ON THE DRIVER. THE SURGEON THEN INSERTED THE K-WIRE WITH A MAZAR ROBOT ON THE RIGHT SIDE AND INSERTED SCREWS IN BOTH L4 & L5 AND THEN INSERTED LEFT SIDE SCREWS. THE ROD WAS PLACED ON THE LEFT SIDE, LOCKING CAPS WERE ASSEMBLED AND TORQUED. THE PHYSICIAN ASSISTANT WAS THEN USING THE GOLD SHAFT HEIGHT ADJUSTER AND WHEN THE HEIGHT ADJUSTER WAS PULLED OFF, THE TULIP HAD DISASSEMBLED AND WAS STILL IN THE ADJUSTER. THE PEDICLE SCREW WAS THEN REMOVED AND REPLACED WITH A NEW SCREW / TULIP ASSEMBLY OF THE SAME SIZE AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER INCIDENT. THERE WAS NO PATIENT INJURY, BUT A 2 1/2 MINUTE DELAY TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17365372 ↗
• InjuryMay 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2023, UTILIZING THE REFORM TI MIS PEDICLE SCREW SYSTEM. THE MODULAR POLYAXIAL TULIP ASSEMBLY (64-MT-0403) WAS POPPED ONTO THE Ø6.5MM X 45MM REFORM TI MODULAR CANNULATED SCREW (39-SK-6545) IN THE CADDY. THE TECH THEN PULLED ON THE BONE SCREW TO CHECK FOR PROPER ASSEMBLY. THE ASSEMBLED SCREW AND TULIP WAS THEN INSERTED WITH THE POLYAXIAL SCREWDRIVER AND WHEN THE SCREWDRIVER WAS REMOVED FROM THE SCREW THE TULIP HEAD POPPED OFF THE SCREW. AT THIS TIME A NEW K-WIRE WAS INSERTED AND THE BONE SCREW WAS BACKED OUT OF THE PEDICLE. ANOTHER SCREW AND TULIP WERE ASSEMBLED AND IMPLANTED WITH NO FURTHER ISSUE. THERE WAS A FIVE (5) MINUTE DELAY TO THE PROCEDURE DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16949973 ↗
• InjuryDec 21, 2022Misassembled

  IT WAS REPORTED THAT A ONE-LEVEL PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE, UTILIZING THE REFORM MIS TI CT PEDICLE SCREW SYSTEM. IT WAS NOTED DURING FINAL RADIOGRAPHS TAKEN DURING THE PROCEDURE SHOW THAT ONE OF THE MODULAR POLYAXIAL TULIP ASSEMBLY REFORM MIS PEDICLE SCREW (64-MT-0403) WAS NOT ASSEMBLED TO THE SCREW. THE SCREW WAS THEN REMOVED AND REPLACED WITH A NEW SCREW/TULIP ASSEMBLY. THERE WAS NO PATIENT INJURY BUT A 20-30 MINUTE DELAY RESULTED. THE DISASSEMBLED PRODUCT WAS DISCARDED IN THE OPERATING ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16024214 ↗
• MalfunctionAug 15, 2022Detachment of Device or Device Component

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2022, UTILIZING THE REFORM TI MIS CT PEDICLE SCREW SYSTEM. THE MODULAR POLYAXIAL TULIP ASSEMBLY REFORM MIS PEDICLE SCREW SYS (64-MT-0403) AND REFORM TI MODULAR CANNULATED SCREWS WERE ASSEMBLED BY THE TECH ON THE BACK TABLE AND HANDED OFF TO THE SURGEON. THE SCREW/TULIP ASSEMBLIES WERE THEN IMPLANTED INTO THE PEDICLE. UPON ATTEMPTING TO INSERT THE ROD THROUGH THE TULIPS, ONE OF THE MODULAR POLYAXIAL TULIP ASSEMBLIES DISASSEMBLED FROM THE SCREW. THE SURGEON WAS ABLE TO SNAP A NEW TULIP ONTO THE SCREW AND SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO DELAY TO THE PROCEDURE OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15229282 ↗
• MalfunctionAug 15, 2022Misassembled; Output Problem

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2022, UTILIZING THE REFORM TI MIS CT PEDICLE SCREW SYSTEM. THE MODULAR POLYAXIAL TULIP ASSEMBLY REFORM MIS PEDICLE SCREW SYS (64-MT-0403) AND REFORM TI MODULAR CANNULATED SCREWS WERE ASSEMBLED BY THE TECH ON THE BACK TABLE AND HANDED OFF TO THE SURGEON. THE SCREW/TULIP ASSEMBLIES WERE THEN IMPLANTED INTO THE PEDICLE. UPON ATTEMPTING TO INSERT THE ROD THROUGH THE TULIPS, ONE OF THE MODULAR POLYAXIAL TULIP ASSEMBLIES DISASSEMBLED FROM THE SCREW. THE SURGEON WAS ABLE TO SNAP THE TULIP BACK ONTO THE SCREW AND SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO DELAY TO THE PROCEDURE OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15225369 ↗
• InjuryJul 18, 2022Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2022, IN AUSTRALIA, UTILIZING THE REFORM TI MIS CT MODULAR PERCUTANEOUS SCREW SYSTEM. UPON FINAL TIGHTENING OF ONE OF THE SET SCREWS, THE MODULAR POLYAXIAL TULIP ASSEMBLY REFORM MIS PEDICLE SCREW SYSTEM (39-MT-0403) SLOWLY MOVED UP OFF OF THE SCREW AND OUT OF THE PATIENT. THE SCREW WAS THEN REMOVED, AND A SECOND SCREW AND TULIP WERE ASSEMBLED AND IMPLANTED WITH NO FURTHER ISSUE. THERE WAS A SLIGHT (A FEW MINUTES) DELAY TO THE PROCEDURE BECAUSE OF THIS MALFUNCTION, BUT NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15041697 ↗