4.5mm BONE-LOK PLS Implant LSW-45-4555Recalls & reported problems

Interventional Spine, Inc · 4.5mm O.D. x 45-55mm Length · Class U

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811954013219), received between Mar 6, 2018 and Mar 6, 2018 — classified as 1 injury.

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

Adverse Event Without Identified Device or Use Problem1

Patient problems

Not Applicable1
Spinal Column Injury1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryMar 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED, REVISION SURGERY FOR THE INTERVENTIONAL SPINE FACET SCREW (PRODUCT CODE/DESCRIPTION BELOW) OCCURRED ON FRIDAY (B)(6) 2018. REVISION SURGERY WENT WELL WITH A DEPUY SPINE REVISION SET. NO FURTHER INFORMATION KNOWN. PART NUMBER FOR ISPINE SCREW 9024-01 (UNRECOGNIZED PART IN UNITY) REASON FOR REVISION IS UNKNOWN.
Patient problems: Not Applicable; Spinal Column Injury
MAUDE report 7316144 ↗

Device details

UDI-DI	`00811954013219`
Brand	4.5mm BONE-LOK PLS Implant
Model	LSW-45-4555
Catalog no.	9024-02
Company	Interventional Spine, Inc
Product code	MRW · System, Facet Screw Spinal Device
Class	Class U
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 2, 2025

Device type (GMDN): Bone-screw internal spinal fixation system, sterile

An assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.

Other System, Facet Screw Spinal Device devices

ZYFUSE 147.541S
Globus Medical, Inc. · SYSTEM, FACET SCREW SPINAL DEVICE
1 report
Zyfix Spinal Facet Screw System X076-0020
Xtant Medical Holdings, Inc. · SYSTEM, FACET SCREW SPINAL DEVICE
1 report
VIPER 175710130
Medos International Sàrl · SYSTEM, FACET SCREW SPINAL DEVICE
1 report
CORRIDOR 148.540
Globus Medical, Inc. · SYSTEM, FACET SCREW SPINAL DEVICE
1 report
VIPER 175710535
Medos International Sàrl · SYSTEM, FACET SCREW SPINAL DEVICE
1 report
ION 55 Facet Implant - Sterile TI-K-55
Surgentec, LLC · System, Facet Screw Spinal Device
1 report

All System, Facet Screw Spinal Device 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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