Reform Ti Modular 39-SK-7545Recalls & reported problems
Precision Spine, Inc. · Ø7.5 x 45mm Modular Bone Screw, Cannulated · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840019933698), received between Jul 17, 2023 and Jul 17, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 17, 2023Break; Break
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2023, UTILIZING THE REFORM TI MIS CT PEDICLE SCREW SYSTEM. UPON SCREW INSERTION THE TIP OF TWO POLYAXIAL DRIVER ASSEMBLY, CANNULATED REFORM MIS SYSTEM (64-SP-1700) AND ONE ADJUSTMENT DRIVE, REFORM MIS PEDICLE SYSTEM (64-SP-0601) BROKE. A 07.5MM X 45MM REFORM TI MODULAR CANNULATED SCREW (64-SK-7545) ALSO SHEARED AT THE NECK. THE SHEARED SCREW WAS REMOVED AND REPLACED. NO BROKEN TIPS WERE LEFT IN THE PATIENT, BUT THERE WAS A 45-55 MINUTE DELAY TO THE PROCEDURE DUE TO THE MALFUNCTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17337181 ↗
Other Appliance, Fixation, Spinal Interlaminal devices
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- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 reports
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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