Reform Ti Modular 39-MT-0402Recalls & reported problems
Precision Spine, Inc. · Modular Reduction Tulip · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840019932639), received between Aug 12, 2024 and Aug 12, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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
- Detachment of Device or Device Component2
- Mechanical Problem2
Patient problems
- Implant Pain2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 12, 2024Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2024. SUBSEQUENTLY THE PATIENT PRESENTED WITH PAIN AND X-RAYS FOUND THAT ONE OF THE REFORM TI MODULAR REDUCTION TULIP ASSEMBLIES (39-MT-0402) DISASSEMBLED FROM THE Ø7.5MM X 50MM REFORM TI MODULAR NON-CANNULATED SCREW (39-SP-7550). REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2024, DURING WHICH THE TULIP AND SCREW SHANK WERE REMOVED AND REPLACED ALONG WITH ONE ROD COMPONENT.
Patient problems: Implant Pain
MAUDE report 19961931 ↗InjuryAug 12, 2024Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2024. SUBSEQUENTLY THE PATIENT PRESENTED WITH PAIN AND X-RAYS FOUND THAT ONE OF THE REFORM TI MODULAR REDUCTION TULIP ASSEMBLIES (39-MT-0402) DISASSEMBLED FROM THE Ø7.5MM X 50MM REFORM TI MODULAR NON-CANNULATED SCREW (39-SP-7550). REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2024, DURING WHICH THE TULIP AND SCREW SHANK WERE REMOVED AND REPLACED ALONG WITH ONE ROD COMPONENT.
Patient problems: Implant Pain
MAUDE report 19961923 ↗
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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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