Reform Midline Cortical Screw System 59-BP-6545Recalls & reported problems

Precision Spine, Inc. · Ø6.5 x 45mm Midline Cortical Bone Screw · 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 00815362026342), received between Jun 25, 2024 and Jul 8, 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

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

Most reported problems

Device problems

Detachment of Device or Device Component2

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.

InjuryJul 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED IN AUSTRALIA ON (B)(6) 2024, UTILIZING THE REFORM MC MIDLINE CORTICAL SCREW SYSTEM. DURING THE PROCEDURE THE REFORM TI MODULAR POLYAXIAL TULIP ASSEMBLY (39-MT-0401) WAS ASSEMBLED ONTO THE MIDLINE CORTICAL BONE SCREW (59-BP-XXXX) ON THE NURSES TABLE. THE ASSEMBLED SCREW WAS LOADED ONTO A T25 CANNULATED POLY DRIVER W/LOCK (C3164) AND THE DRIVER WAS TIGHTENED AND LOCKED. THE SCREW WAS PLACED INTO THE PATIENT AND WHEN THE SCREWDRIVER WAS RELEASED FROM THE SCREW THE TULIP DISASSEMBLED FROM THE SCREW AND DROPPED INTO THE WOUND. THE TULIP WAS RETRIEVED USING FORCEPS AND WAS SNAPPED BACK ONTO THE SCREW BY THE SURGEON AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY AND AN APPROXIMATE 5 MINUTE DELAY TO THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19689190 ↗
InjuryJun 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED IN AUSTRALIA ON (B)(6) 2024, UTILIZING THE REFORM MC MIDLINE CORTICAL SCREW SYSTEM. WHILE INSERTING A REFORM TI MODULAR POLYAXIAL TULIP ASSEMBLY (39-MT-0401) ASSEMBLED ON A Ø6.5 X 45MM MIDLINE CORTICAL BONE SCREW (59-BP-6545) THE TULIP CAME OFF OF THE SCREW WHEN THE DRIVER WAS REMOVED. THE TULIP DROPPED INTO THE WOUND AND WAS RETRIEVED USING FORCEPS. THE TULIP WAS THEN SNAPPED BACK ONTO THE SCREW SHANK AND THE PROCEDURE WAS COMPLETED WITH ONLY A SHORT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19608477 ↗

Device details

UDI-DI	`00815362026342`
Brand	Reform Midline Cortical Screw System
Model	59-BP-6545
Company	Precision Spine, Inc.
Product code	NKB · Thoracolumbosacral Pedicle Screw System
Class	Class 2
FDA submission	K173130
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

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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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