Reform TI Pedicle Screw System 39-SG-5550Recalls & reported problems
Precision Spine, Inc. · Ø5.5 x 50mm Modular Bone Screw, Non-Fluted · 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 00840019940078), received between Dec 10, 2020 and Dec 10, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break2
Patient problems
- Pain2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 10, 2020Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2020, UTILIZING THE REFORM TI MODULAR PEDICLE SCREW SYSTEM. SUBSEQUENTLY, AT SOME TIME AROUND (B)(6) 2020, THE PATIENT WAS EXPERIENCING PAIN AND X-RAYS INDICATE THAT TWO (2) OF THE ¿5.5MM X 50MM REFORM TI MODULAR NON-CANNULATED - NO TAPPING FLUTE SCREWS (39-SG-5550) ARE BROKEN MID-SHAFT. REVISION WAS PERFORMED ON (B)(6) 2020 DURING WHICH THE BROKEN SCREWS WERE REMOVED AND REPLACED.
Patient problems: Pain
MAUDE report 10987498 ↗InjuryDec 10, 2020Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2020, UTILIZING THE REFORM TI MODULAR PEDICLE SCREW SYSTEM. SUBSEQUENTLY, AT SOME TIME AROUND (B)(6) 2020, THE PATIENT WAS EXPERIENCING PAIN AND X-RAYS INDICATE THAT TWO (2) OF THE Ø5.5MM X 50MM REFORM TI MODULAR NON-CANNULATED - NO TAPPING FLUTE SCREWS (39-SG-5550) ARE BROKEN MID-SHAFT. REVISION WAS PERFORMED ON (B)(6) 2020 DURING WHICH THE BROKEN SCREWS WERE REMOVED AND REPLACED.
Patient problems: Pain
MAUDE report 10987440 ↗
Other Thoracolumbosacral Pedicle Screw System devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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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