Reform TI Pedicle Screw System 39-SB-5545Recalls & reported problems

Precision Spine, Inc. · Modular Bone Screw, 5.5mm x 45mm, Gold · 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 00840019931878), received between Oct 13, 2023 and Oct 13, 2023 — 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Break2
Fracture2

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryOct 13, 2023Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE TO ADDRESS AN L1 FRACTURE ON (B)(6) 2023. THE SURGEON PUT SCREWS AT T12 AND AT L2 AND DID A LAMINECTOMY AT L1, UTILIZING THE REFORM TI MODULAR CANNULATED PEDICLE SCREW SYSTEM. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON SEPTEMBER 18, 2023, TO ADDRESS TWO BROKEN Ø5.5MM X 45MM REFORM TI MODULAR NON-CANNULATED SCREWS (B)(6). THE TOP TWO SCREWS IN THE CONSTRUCT WERE FOUND TO BE BROKEN AND WERE REMOVED WITH FORCEPS, THE BOTTOM TWO SCREW WERE ALSO REMOVED WITH A DRIVER AND T-HANDLE. NO NEW HARDWARE WAS IMPLANTED AS THE SURGEON FELT THERE WAS ADEQUATE FUSION ACROSS THE FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17931185 ↗
InjuryOct 13, 2023Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE TO ADDRESS AN L1 FRACTURE ON (B)(6) 2023. THE SURGEON PUT SCREWS AT T12 AND AT L2 AND DID A LAMINECTOMY AT L1, UTILIZING THE REFORM TI MODULAR CANNULATED PEDICLE SCREW SYSTEM. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2023, TO ADDRESS TWO BROKEN Ø5.5MM X 45MM REFORM TI MODULAR NON-CANNULATED SCREWS (B)(6). THE TOP TWO SCREWS IN THE CONSTRUCT WERE FOUND TO BE BROKEN AND WERE REMOVED WITH FORCEPS, THE BOTTOM TWO SCREW WERE ALSO REMOVED WITH A DRIVER AND T-HANDLE. NO NEW HARDWARE WAS IMPLANTED AS THE SURGEON FELT THERE WAS ADEQUATE FUSION ACROSS THE FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17931184 ↗

Device details

UDI-DI	`00840019931878`
Brand	Reform TI Pedicle Screw System
Model	39-SB-5545
Company	Precision Spine, Inc.
Product code	NKB · Thoracolumbosacral Pedicle Screw System
Class	Class 2
FDA submission	K150856
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 11, 2024

Device type (GMDN): Spinal bone screw, non-bioabsorbable

A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Other Thoracolumbosacral Pedicle Screw System devices

EXPEDIUM VERSE 199721000
Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease
387 reports
Sequoia® 3301-1
Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
184 reports
CD HORIZON® Spinal System 8590855
Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
179 reports
Vitality® 07.02011.001
Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease
3 recalls0 reports
EXPEDIUM VERSE 199721001S
Medos International Sàrl · Thoracolumbosacral pedicle screw system
124 reports
LineSider LS-N6SA7550
Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System
2 recalls1 report
LineSider LS-N6SA6545
Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System
2 recalls0 reports
EXPEDIUM VERSE 199721000S
Medos International Sàrl · Thoracolumbosacral pedicle screw system
97 reports

All Thoracolumbosacral Pedicle Screw System devices →

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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