Reform Pedicle Screw SystemRecalls & reported problems across all models
Precision Spine, Inc. · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 149
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls
- 0
We found 11 models of Reform Pedicle Screw System by Precision Spine, Inc. in the FDA's device registry (GUDID). Together they are named in 149 adverse event reports in the FDA's MAUDE database, received between Oct 17, 2019 and Mar 20, 2026 — classified as 34 injuries, 115 malfunctions.
The most frequently reported specific device problem is “Break” (90 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
Reports received per month, all models
Most reported Reform Pedicle Screw System problems
Device problems
- Break90
- Fracture56
- Appropriate Device Problem Term/Code Not Available3
- Detachment of Device or Device Component3
- Difficult to Remove3
- Entrapment of Device2
- Crack1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions111
- Insufficient Information16
- No Known Impact Or Consequence To Patient9
- Foreign Body In Patient7
- No Consequences Or Impact To Patient3
- Device Embedded In Tissue or Plaque1
- No Code Available1
- Tissue Damage1
Reform Pedicle Screw System models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Reform Pedicle Screw System 39-RD-0060Screwdriver112 reports
- Reform Pedicle Screw System 39-SP-0700Screwdriver10 reports
- Reform Pedicle Screw System HXX-39-0001Screwdriver9 reports
- Reform Pedicle Screw System 39-SP-0601Screwdriver7 reports
- Reform Pedicle Screw System 39-SP-0730Screwdriver3 reports
- Reform Pedicle Screw System 39-PA-8570Orthosis, Spinal Pedicle Fixation2 reports
- Reform Pedicle Screw System 39-SC-5500Appliance, Fixation, Spinal Interlaminal2 reports
- Reform Pedicle Screw System 39-PA-1050Thoracolumbosacral Pedicle Screw System1 report
- Reform Pedicle Screw System 39-RP-6535Orthosis, Spinal Pedicle Fixation1 report
- Reform Pedicle Screw System 39-CH-0008Orthopedic Manual Surgical Instrument1 report
- Reform Pedicle Screw System 39-SP-0565Bit, Drill1 report
Recent Reform 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.
InjuryMar 20, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2026, BY DR. (B)(6), UTILIZING THE VAULT C ACDF SYSTEM. AS THE SCREWS WERE ABOUT TO BE INSERTED, THE ANTERIOR PLATE SEPARATED FROM THE POSTERIOR CAGE. UPON INSPECTION, A TINE ON THE ANTERIOR PLACE WAS FOUND TO BE BENT AND UNUSABLE. THE PLATE AND CAGE WERE REMOVED AND REPLACED WITH OTHER IMPLANTS OF THE SAME SIZE, READILY AVAILABLE IN THE SET. THERE WAS NO PATIENT INJURY ANY ONLY MINIMAL DELAY TO THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24653932 ↗MalfunctionJan 6, 2026Fracture
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2025, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. DURING FINAL TORQUE OF THE SURGEON USED THE ANTI-TORQUE WRENCH ON THE SCREW HEAD WHILE TIGHTENING THE LOCK SCREW IN THE OPPOSITE DIRECTION OF THE NUT. AT THAT TIME, THE TIP OF THE T25, LOCK-SCREW TORQUE DRIVER, REFORM (39-RD-0060) BROKE. THE BROKEN TIP PIECE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED UTILIZING THE SECOND LOCK SCREWDRIVER READILY AVAILABLE IN THE SET. THERE WAS A TWO-MINUTE DELAY TO THE PROCEDURE, BUT NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23981508 ↗MalfunctionJan 6, 2026Fracture
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2025, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. DURING FINAL TORQUE OF THE SURGEON USED THE ANTI-TORQUE WRENCH ON THE SCREW HEAD WHILE TIGHTENING THE LOCK SCREW IN THE OPPOSITE DIRECTION OF THE NUT. AT THAT TIME, THE TIP OF THE T25, LOCK-SCREW TORQUE DRIVER, REFORM (39-RD-0060) BROKE. THE BROKEN TIP PIECE WAS REMOVED AND THE PROCEDURE WAS COMPLETED UTILIZING THE SECOND LOCK SCREWDRIVER READILY AVAILABLE IN THE SET. THERE WAS A TWO-MINUTE DELAY TO THE PROCEDURE BUT NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23981507 ↗MalfunctionJan 6, 2026Fracture
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2025, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. DURING FINAL TORQUE OF THE SURGEON USED THE ANTI-TORQUE WRENCH ON THE SCREW HEAD WHILE TIGHTENING THE LOCK SCREW IN THE OPPOSITE DIRECTION OF THE NUT. AT THAT TIME, THE TIP OF THE T25, LOCK-SCREW TORQUE DRIVER, REFORM (39-RD-0060) BROKE. THE BROKEN TIP PIECE WAS REMOVED AND THE PROCEDURE WAS COMPLETED UTILIZING THE SECOND LOCK SCREWDRIVER READILY AVAILABLE IN THE SET. THERE WAS A TWO-MINUTE DELAY TO THE PROCEDURE BUT NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23981503 ↗MalfunctionJan 6, 2026Fracture
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2025, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. DURING FINAL TORQUE OF THE SURGEON USED THE ANTI-TORQUE WRENCH ON THE SCREW HEAD WHILE TIGHTENING THE LOCK SCREW IN THE OPPOSITE DIRECTION OF THE NUT. AT THAT TIME, THE TIP OF THE T25, LOCK-SCREW TORQUE DRIVER, REFORM (39-RD-0060) BROKE. THE BROKEN TIP PIECE WAS REMOVED AND THE PROCEDURE WAS COMPLETED UTILIZING THE SECOND LOCK SCREWDRIVER READILY AVAILABLE IN THE SET. THERE WAS A TWO-MINUTE DELAY TO THE PROCEDURE BUT NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23981502 ↗MalfunctionJan 6, 2026Fracture
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2025, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. DURING FINAL TORQUE OF THE SURGEON USED THE ANTI-TORQUE WRENCH ON THE SCREW HEAD WHILE TIGHTENING THE LOCK SCREW IN THE OPPOSITE DIRECTION OF THE NUT. AT THAT TIME, THE TIP OF THE T25, LOCK-SCREW TORQUE DRIVER, REFORM (39-RD-0060) BROKE. THE BROKEN TIP PIECE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED UTILIZING THE SECOND LOCK SCREW DRIVER READILY AVAILABLE IN THE SET. THERE WAS A TWOMINUTE DELAY TO THE PROCEDURE, BUT NO PATIENT INJURY REPORTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23981501 ↗MalfunctionDec 31, 2025Fracture; Fracture
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2025, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. UPON FINAL TIGHTENING OF THE LOCK SCREWS, THE TIP OF TWO OF THE T25, LOCK-SCREW TORQUE DRIVER, REFORM (39-RD-0060) BROKE. THE BROKEN TIPS WERE REMOVED AND THE PROCEDURE WAS COMPLETED UTILIZING ANOTHER DRIVER READILY AVIALABLE. THERE WAS A FIVE (5) MINUTE DELAY TO THE PROCEDURE BUT NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23936896 ↗MalfunctionDec 31, 2025Fracture; Fracture
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2025, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. UPON FINAL TIGHTENING OF THE LOCK SCREWS, THE TIP OF TWO OF THE T25, LOCK-SCREW TORQUE DRIVER, REFORM (39-RD-0060) BROKE. THE BROKEN TIPS WERE REMOVED AND THE PROCEDURE WAS COMPLETED UTILIZING ANOTHER DRIVER READILY AVIALABLE. THERE WAS A FIVE (5) MINUTE DELAY TO THE PROCEDURE BUT NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23936895 ↗InjuryDec 31, 2025Fracture; Fracture
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2025, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. SURGEON NOTED THE ONE OF THE SCREWS WAS INCORRECTLY POSITION AND DURING ATTEMPTS TO REMOVE IT, THE TIP OF THE RETENTION BONE-SCREWDRIVER (39-SP-0601) BROKE. A SMALL ROD WAS INSERTED INTO THE SCREW AND THE ENTIRE SCREW WAS SUCCESSFULLY REMOVED USING A STRONG ROD HOLDER. THE SURGEON THEN ATTEMPTED TO REPOSITION AND REINSERT THE SAME SCREW. HOWEVER, IT REMAINED INCORRECTLY PLACED AND REQUIRED REMOVAL. DURING THE REMOVAL ATTEMPT THE HEAD OF THE REFORM 8.5 X 70MM POLYAXIAL PEDICLE SCREW (39-PA-8570) FRACTURED. THE SCREW WAS ULTIMATELY EXTRACTED USING A ROD. THE SCREW HEAD BROKE COMPLETELY OFF DURING THE FINAL STAGE OF REMOVAL. WHILE INSERTING A NEW SCREW, THE TIP OF THE POLYAXIAL DRIVER ASSEMBLY REFORM PEDICLE SCREW SYSTEM (39-SP-0730) BROKE. A ROD WAS USED TO REMOVE THE SCREW AS THE DRIVER TIP WAS STUCK IN THE SCREW HEAD, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUE. THERE WAS A FIVE (5) MINUTE DELAY TO THE PROCEDURE AS A RESULT OF THE ISSUES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23936080 ↗MalfunctionDec 12, 2025Fracture; Fracture
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2025, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. DURING FINAL TIGHTENING OF THE LOCK SCREW, THE TIP OF THE T25, LOCK-SCREW TORQUE DRIVER, REFORM (39-RD-0060) BROKE. THE BROKEN TIP WAS REMOVED AND THE PROCEDURE COMPLETED SUCCESSFULLY UTILIZING THE SECOND DRIVER IN THE SET. THERE WAS NO PATIENT INJURY OR DELAY TO THE PROCEDURE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23796383 ↗MalfunctionDec 12, 2025Fracture; Fracture
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON AN UNKNOWNDATE, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. DURING FINAL TIGHTEN OF A LOCK SCREW THE TIP OF THE T25, LOCK-SCREW TORQUE DRIVER, REFORM (39-RD-0060) BROKE. THE BROKEN PIECE WAS REMOVED AND THE PROCEDURE COMPLETED SUCCESSFULLY UTILIZING THE SECOND DRIVER IN THE SET. THERE WAS NO PATIENT INJURY OR SIGNIFICANT DELAY TO THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23796381 ↗MalfunctionDec 9, 2025Fracture; Fracture
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2025, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. DURING THE PROCEDURE WHILE ATTEMPTING TO FINAL TIGHTEN A LOCK SCREW THE TIP OF THE T25, LOCK-SCREW TORQUE DRIVER, REFORM 39-RD-0060) BROKE. THE LOCK SCREW WAS REMOVED AND REPLACED WITH A NEW SCREW AND TIGHTENED USING THE SECOND DRIVER READILY AVAILABLE IN THE SET. THERE WAS NO PATIENT INJURY BUT A FIVE (5) MINUTE DELAY TO THE PROCEDURE AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23759157 ↗MalfunctionAug 20, 2025Fracture; Fracture
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2025, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. WHILE FINAL TIGHTENING A LOCK SCREW, THE T25, LOCK-SCREW TORQUE DRIVER, REFORM (39-RD-0060) TIP BROKE OFF. THE BROKEN TIP WAS REMOVED WITH A PITUITARY AND THE PROCEDURE WAS COMPLETE UTILIZING THE SECOND DRIVER READILY AVAILABLE IN THE SET. THERE WAS NO PATIENT INJURY OR DELAY THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22851835 ↗MalfunctionAug 18, 2025Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2024, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2025 TO EXTEND THE EXISTING CONSTRUCT. DURING THE PROCEDURE IT WAS NOTED THAT ONE OF THE Ø6.5MM X 50MM REFORM TI MODULAR NON-CANNULATED - NON-FLUTED SCREW (39-SG-6550) WAS FRACTURED. THE BROKEN SCREW WAS REMOVED AND REPLACED WITH NEW HARDWARE. IT WAS ALSO NOTED THAT WHILE IMPLANTING A SCREW THE TIP OF THE T20 POLYAXIAL DRIVER REFORM PEDICLE SCREW SYSTEM (39-SP-0730) BROKE. THE TIP WAS REMOVED AND THE PROCEDURE COMPLETED WITH NO FURTHER ISSUE AND NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22834571 ↗MalfunctionAug 11, 2025Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE ON (B)(6)2025, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. SUBSEQUENTLY A REVISION PROCEDURE WAS PERFORMED ON (B)(6)2025. TO EXTEND THE EXISTING CONSTRUCT. DURING THE REVISION PROCEDURE IT WAS NOTED THAT ONE OF THE Ø6.5MM X 50MM REFORM TI MODULAR NON-CANNULATED - NON-FLUTED SCREW (39-SG-6550) WAS BROKEN MID-SHAFT. THE BROKEN SCREW WAS REMOVED AND REPLACED. IT WAS ALSO NOTED THAT THE TIP OF A T25, LOCK-SCREW TORQUE DRIVER (39-RD-0060) BROKE WHILE FINAL TIGHTENING THE LAST LOCK SCREW. THE TIP WAS RECOVERED AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22778877 ↗
Other Precision Spine, Inc. products
All Precision Spine, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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