Whistler Modular Pedicle Screw System WI-003Recalls & reported problems

Evolution Spine LLC · Cannulated Shank Removal Driver · Class 1

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00195860004685), received between Nov 1, 2022 and Nov 1, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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.

Most reported problems

Device problems

Material Fragmentation1

Patient problems

Foreign Body In Patient1

Recent adverse event reports

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

MalfunctionNov 1, 2022Material Fragmentation; Material Fragmentation
THE SURGEON WAS PERFORMING THE FINAL TIGHTENING OF AN INSERTED PEDICLE SCREW/TULIP WHEN THE TIP OF THE DRIVER BROKE FREE OF THE DRIVER. THE SURGEON LEFT THE BROKEN-OFF TIP IN THE HEAD OF THE PEDICLE SCREW AND INSERTED THE ROD AS PER NORMAL PROCEDURE WHICH SECURED THE BROKEN-OFF TIP IN THE PEDICLE SCREW HEAD, PREVENTING IT FROM MIGRATING.
Patient problems: Foreign Body In Patient
MAUDE report 15709174 ↗

Device details

UDI-DI	`00195860004685`
Brand	Whistler Modular Pedicle Screw System
Model	WI-003
Company	Evolution Spine LLC
Product code	LXH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 25, 2021

Device type (GMDN): Surgical screwdriver, reusable

A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

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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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