Reform Pedicle Screw System 39-PA-8570Recalls & reported problems

Precision Spine, Inc. · 8.5 x 70mm Polyaxial Screw · Class 2 · Implant

All models of Reform Pedicle Screw System (11)

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 00840019900515), received between May 19, 2025 and Dec 31, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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

Break1
Fracture1

Patient problems

Insufficient Information1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

InjuryDec 31, 2025Fracture; Fracture
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2025, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. SURGEON NOTED THE ONE OF THE SCREWS WAS INCORRECTLY POSITION AND DURING ATTEMPTS TO REMOVE IT, THE TIP OF THE RETENTION BONE-SCREWDRIVER (39-SP-0601) BROKE. A SMALL ROD WAS INSERTED INTO THE SCREW AND THE ENTIRE SCREW WAS SUCCESSFULLY REMOVED USING A STRONG ROD HOLDER. THE SURGEON THEN ATTEMPTED TO REPOSITION AND REINSERT THE SAME SCREW. HOWEVER, IT REMAINED INCORRECTLY PLACED AND REQUIRED REMOVAL. DURING THE REMOVAL ATTEMPT THE HEAD OF THE REFORM 8.5 X 70MM POLYAXIAL PEDICLE SCREW (39-PA-8570) FRACTURED. THE SCREW WAS ULTIMATELY EXTRACTED USING A ROD. THE SCREW HEAD BROKE COMPLETELY OFF DURING THE FINAL STAGE OF REMOVAL. WHILE INSERTING A NEW SCREW, THE TIP OF THE POLYAXIAL DRIVER ASSEMBLY REFORM PEDICLE SCREW SYSTEM (39-SP-0730) BROKE. A ROD WAS USED TO REMOVE THE SCREW AS THE DRIVER TIP WAS STUCK IN THE SCREW HEAD, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUE. THERE WAS A FIVE (5) MINUTE DELAY TO THE PROCEDURE AS A RESULT OF THE ISSUES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23936080 ↗
InjuryMay 19, 2025Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE WAS PERFORMED ON (B)(6) 2025, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. WHILE ATTEMPTING TO INSERT AN UNKNOWN SCREW, THE TIP OF THET20 POLYAXIAL DRIVER REFORM PEDICLE SCREW SYSTEM (39-SP-0730) BROKE AND SUBSEQUENTLY WHEN TRYING TO REMOVE THE SCREW THE DRIVER BROKE AGAIN. SUBSEQUENTLY, WHEN ATTEMPTING TO INSERT THE SECOND SCREW USING THE RETENTION BONE-SCREWDRIVER (39-SP-0601) THE SCREW BROKE. ADDITIONAL DETAILS HAVE BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22045601 ↗

Device details

UDI-DI	`00840019900515`
Brand	Reform Pedicle Screw System
Model	39-PA-8570
Company	Precision Spine, Inc.
Product code	MNI · Orthosis, Spinal Pedicle Fixation
Class	Class 2
FDA submission	K121172
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 Orthosis, Spinal Pedicle Fixation devices

NA 04.614.508
Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION
277 reports
CREO 1134.0010
Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION
112 reports
CREO 1119.0010
Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION
80 reports
VIPER 186731745
Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION
43 reports
CD HORIZON® Spinal System 1553201090
Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION
38 reports
EXPEDIUM 179902000
Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION
37 reports
CD HORIZON® Spinal System 7540220
Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION
36 reports
EXPEDIUM VERSE 199721640
Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION
35 reports

All Orthosis, Spinal Pedicle Fixation 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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