Reform Ti Modular 39-SK-7550Recalls & reported problems
Precision Spine, Inc. · Ø7.5 x 50mm 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 00840019933704), received between Apr 13, 2022 and Apr 13, 2022 — 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
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 13, 2022Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE PERFORMED ON (B)(6) 2021, UTILIZING THE REFORM TI MIS CT PEDICLE SCREW SYSTEM. A REVISION WAS PERFORMED ON (B)(6) 2022 TO ADDRESS A BROKEN Ø7.5MM X 50MM REFORM TI MODULAR CANNULATED SCREW (39-SK-7550) THAT WAS IDENTIFIED DURING ROUTINE FOLLOW-UP X-RAYS. THE BREAK OCCURRED AT THE NECK JUST BELOW THE SCREW HEAD. THE BROKEN SCREW WAS REMOVED AND REPLACED WITH A 9.5MM X 50MM, AND THE SCREW FROM THE ADJACENT LEVEL WAS REMOVED AND REPLACED WITH AN 8.5MM X 50MM SCREW. IT WAS NOTED THAT FUSION HAD NOT BEEN ACHIEVED AND THE PATIENT WAS COMPLIANT.
Patient problems: Insufficient Information
MAUDE report 14103508 ↗
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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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