Reform Ti Modular 39-SK-6555Recalls & reported problems
Precision Spine, Inc. · Ø6.5 x 55mm Modular Bone Screw, Cannulated · 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 00840019933643), received between Mar 19, 2024 and Mar 19, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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
- Fracture2
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.
InjuryMar 19, 2024Fracture; Fracture
IT WAS REPORTED THAT AN L4/L5/S1 PROCEDURE WAS PERFORMED ON (B)(6) 2023, UTILIZING THE REFORM TI MODULAR CANNULATED PEDICLE SCREW SYSTEM. SUBSEQUENTLY, THE PATIENT PRESENTED WITH PAIN AND RADIOGRAPHICAL ANALYSIS SHOWED COMPRESSION OF THE CONSTRUCT AND THREE (3) BROKEN Ø6.5MM X 55MM REFORM TI MODULAR CANNULATED SCREWS (39-SK-6555). A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2024, DURING WHICH ALL HARDWARE WAS REMOVED AND REPLACED, WITH THE EXCEPTION OF ONE SIDE OF L5 WHERE TIP PORTION OF THE BROKEN SCREW REMAINS.
Patient problems: Implant Pain
MAUDE report 18935456 ↗InjuryMar 19, 2024Fracture; Fracture
IT WAS REPORTED THAT AN L4/L5/S1 PROCEDURE WAS PERFORMED ON (B)(6) 2023, UTILIZING THE REFORM TI MODULAR CANNULATED PEDICLE SCREW SYSTEM. SUBSEQUENTLY, THE PATIENT PRESENTED WITH PAIN AND RADIOGRAPHICAL ANALYSIS SHOWED COMPRESSION OF THE CONSTRUCT AND THREE (3) BROKEN Ø6.5MM X 55MM REFORM TI MODULAR CANNULATED SCREWS (39-SK-6555). A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2024, DURING WHICH ALL HARDWARE WAS REMOVED AND REPLACED, WITH THE EXCEPTION OF ONE SIDE OF L5 WHERE TIP PORTION OF THE BROKEN SCREW REMAINS.
Patient problems: Implant Pain
MAUDE report 18935452 ↗
Other Appliance, Fixation, Spinal Interlaminal devices
- EXPEDIUM 179702000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL439 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page