Reform Pedicle Screw System 39-RD-0060Recalls & reported problems
Precision Spine, Inc. · Lock Screw Torque Driver · Class 1
All models of Reform Pedicle Screw System (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Precision Spine Reform lock screw torque driver is a surgical screwdriver used to tighten screws in spinal surgery. Many of the 112 reports describe the driver tip breaking during final tightening, and some describe a broken piece that had to be removed. The reports include 18 injuries and no deaths, and 4 list a foreign body in the patient. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 112
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 112 adverse event reports that list this exact device (DI 00840019928366), received between Jan 9, 2020 and Mar 20, 2026 — classified as 18 injuries, 94 malfunctions.
The most frequently reported specific device problem is “Break” (64 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.
Reports received per month
Most reported problems
Device problems
- Break64
- Fracture46
- Detachment of Device or Device Component2
- Difficult to Remove2
- Entrapment of Device2
- Crack1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions90
- Insufficient Information12
- Foreign Body In Patient4
- No Known Impact Or Consequence To Patient3
- No Consequences Or Impact To Patient2
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 25 most recent of 112 reports, 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 ↗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 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 ↗MalfunctionJul 11, 2025Fracture; Fracture
IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. DURING ATTEMPTED REMOVAL OF A PREVIOUSLY TORQUED LOCK SCREW, THE TIP OF THE T25, LOCK-SCREW TORQUE DRIVER, REFORM (39-RD-0060) BROKE. THE TIP WAS RETRIEVED AND DISCARDED, AND THE PROCEDURE WAS COMPLETED UTILIZING OTHER INSTRUMENTATION READILY AVAILABLE. THERE WAS NO PATIENT INJURY OR DELAY TO THE PROCEDURE REPORTED. REASON FOR NEED FOR REVISION IS UNKNOWN AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22481113 ↗MalfunctionJun 16, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING PROCEDURE PERFORMED ON (B)(6) 2025, THE TIP OF A T25, LOCK-SCREW TORQUE DRIVER, REFORM (39-RD-0060) BROKE WHEN FINAL TIGHTENING A LOCK SCREW. THE TIP WAS REMOVED AND THE PROCEDURE WAS COMPLETED UTILIZING THE SECOND LOCK- SCREW TORQUE DRIVER, REFORM (39-RD-0060) AND A T25 DRIVER, PERSUADER, LONG (C3492) THAT WERE READILY AVAILABLE. THERE WAS NO PATIENT INJURY OR SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22211646 ↗MalfunctionApr 21, 2025Fracture; Fracture
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2025, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. DURING THE PROCEDURE THE TIP OF THE T25, LOCK-SCREW TORQUE DRIVER, REFORM (39-RD-0060) BROKE. THE BROKEN TIP WAS RETRIEVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED UTILIZING THE SECOND DRIVER READILY AVAILABLE IN THE SET. THERE WAS NO PATIENT INJURY BUT A SLIGHT, TWO-MINUTE DELAY TO THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21877509 ↗MalfunctionMar 24, 2025Fracture; Fracture
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2025, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. DURING FINAL TIGHTENING THE TIP OF A T25, LOCK-SCREW TORQUE DRIVER, REFORM BROKE OFF. THE TIP WAS RETRIEVED AND X-RAYS WERE TAKEN TO ASSURE NO FRAGMENTS WERE MISSED. ANOTHER DRIVER WAS PUILLED FROM A BACKUP SET AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJIURY OR DELAY TO THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21684210 ↗MalfunctionDec 11, 2024Fracture; Fracture
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE THE TIP OF A T25, LOCK-SCREW TORQUE DRIVER, REFORM (39-RD-0060) AND A T25 DRIVER, PERSUADER, LONG (C3492) BOTH BROKE. THE TIPS WERE RECOVERED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED UTILIZING OTHER INSTRUMENTATION READILY AVAILABLE. THERE WAS NO PATIENT INJURY OR DELAY TO THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20902594 ↗MalfunctionNov 8, 2024Fracture; Fracture
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2024, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. DURING THE PROCEDURE, WHILE FINAL TIGHTENING THE SET SCREWS UTILIZING THE OFFSET RATCHETING TORQUE HANDLE (39-CH-0008) WITH THE T25, LOCK- SCREW TORQUE DRIVER, REFORM (39-RD-0060) THE TIP OF THE DRIVER BROKE. THE BROKEN TIP WAS REMOVED AND THE PROCEDURE WAS COMPLETED UTILIZING THE SECOND 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 20641459 ↗MalfunctionOct 17, 2024Fracture; Fracture
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2024, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. WHILE FINAL TIGHTENING THE LOCK SCREWS THE TIP OF THE T25, LOCK-SCREW TORQUE DRIVER, REFORM (39-RD-0060) BROKE. THE BROKEN TIP WAS REMOVED USING A RONGEUR AND THE PROCEDURE WAS COMPLETED UTILIZING THE SECOND DRIVER READILY AVAILABLE IN THE SET. THERE WAS NO PATIENT INJURY, BUT A FIVE (5) MINUTE DELAY TO THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20476057 ↗MalfunctionJul 26, 2024Fracture; Fracture
IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2024, UTILIZING THE REFORM PEDICLE SCREW SYSTEM, TO EXTEND AN EXISTING CONSTRUCT FROM A COMPETITOR. WHILE ATTEMPTING TO REMOVE THE COMPETITOR'S EXISTING HARDWARE, THE TIP OF THE LOCK-SCREW TORQUE DRIVER (39-RD-0060) BROKE. THE SCREW WAS "HELICOPTERED" OUT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19838629 ↗MalfunctionJul 12, 2024Fracture; Fracture
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED IN THE DOMINICAN REPUBLIC ON (B)(6) 2024, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. UPON ASSEMBLING THE LOCK SCREWS THE DOCTOR PLACED THE ANTI-TORQUE AND WHEN APPLYING FINAL TORQUE, THE TIP OF THE T25, LOCK-SCREW TORQUE DRIVER, REFORM (30-RD-0060) BROKE.THE BROKEN TIP WAS REMOVED AND THE LOCK SCREW WAS FINAL TIGHTENED UTILIZING THE SECOND DRIVER READILY AVAILABLE IN THE SET. SUBSEQUENTLY, UPON TIGHTENING THE FINAL LOCK SCREW, THE TIP OF THE SECOND T25, LOCK-SCREW TORQUE DRIVER, REFORM (39-RD-0060) BROKE. THE BROKEN TIP PIECE WAS REMOVED AND THE LOCK SCREW ULTIMATELY TIGHTENED USING THE LOCK SCREW RETENTION DRIVE (39-RD-0602) WITH HAND PRESSURE. THERE WAS NO PATIENT INJURY, BUT A TEN (10) MINUTE DELAY TO THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19731402 ↗MalfunctionJul 12, 2024Fracture; Fracture
IT WAS REPORTED THAT A PROCEDURE WAS PERFOMRED IN THE DOMINICAN REPUBLIC ON (B)(6) 2024, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. UPON ASSEMBLYING THE LOCK SCREWS THE DOCTOR PLACED THE ANTI-TORQUE AND WHEN APPLYING FINAL TORQUE, THE TIP OF THE T25, LOCK-SCREW TORQUE DRIVER, REFORM (30-RD-0060) BROKE.THE BROKEN TIP WAS REMOVED AND THE LOCK SCREW WAS FINAL TIGHTENED UTILIZING THE SECOND DRIVER READILY AVAILABLE IN THE SET. SUBSEQUENTLY, UPON TIGHTENING THE FINAL LOCK SCREW, THE TIP OF THE SECOND T25, LOCK-SCREW TORQUE DRIVER, REFORM (39-RD-0060) BROKE. THE BROKEN TIP PIECE WAS REMOVED AND THE LOCK SCREW ULTIMATELY TIGHTENED USING THE LOCK SCREW RETENTION DRIVE (39-RD-0602) WITH HAND PRESSURE. THERE WAS NO PATIENT INJURY, BUT A TEN (10) MINUTE DELAY TO THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19731397 ↗MalfunctionJun 28, 2024Fracture; Fracture
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2024, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. DURING THE PROCEDURE WHILE FINAL TIGHTENING THE LOCK SCREWS, THE TIP OF THE T25, LOCK-SCREW TORQUE DRIVER, REFORM (39-RD-0060) BROKE WHILE USING A COUNTER TORQUE WRENCH. THE BROKEN TIP WAS REMOVED AND THE PROCEDURE COMPLETED UTILIZING THE SECOND DRIVER 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 19633103 ↗MalfunctionJun 27, 2024Fracture; Fracture
IT WAS REPORTED THAT A REVISION PROCEDURE TO EXTEND AN EXISTING CONSTRUCT WAS PERFORMED ON (B)(6) 2024, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. DURING THE PROCEDURE WHILE ATTEMPTING TO REMOVE THE EXISTING LOCK SCREWS, THE TIPS OF TWO (2) T25, LOCK-SCREW TORQUE DRIVER, REFORM (39-RD-0060) BROKE. THE TIPS WERE RECOVERED AND THE PROCEDURE WAS COMPLETE UTILIZING OTHER INSTRUMENTATION READILY AVAILABLE. THERE WAS NO PATIENT INJURY OR DELAY TO THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19629190 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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