Reform Ti CT Modular MIS Pedicle Screw SystemRecalls & reported problems across all models

We found 5 models of Reform Ti CT Modular MIS Pedicle Screw System by Precision Spine, Inc. in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Jul 18, 2022 and Jul 30, 2026 — classified as 16 injuries, 8 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Reform Ti CT Modular MIS Pedicle Screw System problems

Reform Ti CT Modular MIS Pedicle Screw System models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Reform Ti CT Modular MIS Pedicle Screw System 64-MT-0403

  Thoracolumbosacral Pedicle Screw System
  16 reports
• Reform Ti CT Modular MIS Pedicle Screw System 64-SP-1700

  Screwdriver
  3 reports
• Reform Ti CT Modular MIS Pedicle Screw System 64-RD-9010

  Orthopedic Manual Surgical Instrument
  3 reports
• Reform Ti CT Modular MIS Pedicle Screw System 64-SP-0601

  Screwdriver
  1 report
• Reform Ti CT Modular MIS Pedicle Screw System 64-LS-0100

  Thoracolumbosacral Pedicle Screw System
  1 report

Recent Reform Ti CT Modular MIS Pedicle Screw System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50091951 ↗
• InjuryJun 30, 2026Fracture

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2026. AFTER PLACEMENT OF THE SCREW THE SURGEON WENT BACK TO ADJUST. THE ADJUSTMENT COULD NOT BE MADE WITH THE ADJUSTMENT DRIVER (64-SP-0601) SO HE ASKED FOR THE GLOBUS ROBOT DRIVER (75-RT-1750) SO MUCH FORCE WAS APPLIED WHEN TRYING TO TURN THE SCREW THE DRIVER SNAPPED NEAR HANDLE. WE THEN TRIED USING THE (64-SP-1700) AND THE SAME RESULT OCCURRED. WE THEN PLACED A ROD IN THE TULIP AND ATTEMPTED TO USE A SHUKLA TO HELICOPTER IT OUT. THIS RESULTED IN THE NECK OF THE SCREW SNAPPING. NOW WITH THE SHANK OF THE SCREW LEFT IN THE PATIENT WE USED A SHUKLA BROKEN STRIPPED SCREW EXTRACTOR AND WERE ABLE TO REMOVE THE REMAINDER OF THE SCREW. THERE WAS NO PATIENT INJURY, BUT THERE WAS A TWENTY (20) MINUTE DELAY TO THE PROCEDURE AS A RESULT OF THE MALFUNCTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25667761 ↗
• 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 ↗
• InjuryMar 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED IN AUSTRALIA ON (B)(6) 2023, UTILIZING THE REFORM TI MIS CT PEDICLE SCREW SYSTEM. DURING INSERTION OF A ROD, THE TIP OF THE ROD INSERTER ASSEMBLY (B)(6) BROKE WHILE TRYING TO MANIPULATE IT INTO POSITION. THE BROKEN FRAGMENT PIECE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED AS USUAL AS THE ROD WAS IN PLACE WHEN THE TIP BROKE. THERE WAS A 5 MINUTE DELAY TO THE PROCEDURE RESULTING FROM THE BROKEN INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18818735 ↗
• InjuryMar 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED IN (B)(6) ON (B)(6), UTILIZING THE REFORM TI MIS CT PEDICLE SCREW SYSTEM. DURING INSERTION OF A ROD, THE TIP OF THE ROD INSERTER ASSEMBLY (64-RD-9010) BROKE WHILE TRYING TO MANIPULATE IT INTO POSITION. THE PROCEDURE WAS COMPLETED AS USUAL AS THE ROD WAS IN PLACE WHEN THE TIP BROKE. THERE WAS A 5-10 MINUTE DELAY TO THE PROCEDURE RESULTING FROM THE BROKEN INSTRUMENT. A SECOND SURGERY WAS PERFORMED ON AN UNKNOWN DATE TO RECOVER THE BROKEN FRAGMENT FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18817676 ↗
• 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 ↗

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