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Reform Ti CT Modular MIS Pedicle Screw System 64-SP-0601Recalls & reported problems

Precision Spine, Inc. · Adjustment Driver - T25 · Class 1

All models of Reform Ti CT Modular MIS Pedicle Screw System (5)

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 00840019942461), 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 17337172 ↗

Other Screwdriver devices

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Sources and updates

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