N/A X0411333Recalls & reported problems

Medtronic Sofamor Danek, Inc. · DRILL BIT X0411333 ADJUSTABLE CANCELLOUS · Class 1

Data updated Oct 16, 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 00643169000896), received between May 3, 2023 and May 3, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (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 16, 2026.

Most reported problems

Device problems

Use of Device Problem1

Patient problems

Nerve Damage1

Recent adverse event reports

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

InjuryMay 3, 2023Use of Device Problem; Use of Device Problem
CITATION: SHARON KA PO. TAM, PAOLO A. BOLOGNESE, ROGER W. KULA, ANDREW BRODBELT, MANSOOR FOROUGHI, MARAT AVSHALUMOV, DENMARK MUGUTSO AND ILENE RUHOY. SAFETY ANALYSIS AND COMPLICATIONS OF CONDYLAR SCREWS IN A SINGLE-SURGEON SERIES OF 250 OCCIPITOCERVICAL FUSIONS. A RETROSPECTIVE STUDY. ACTA NEUROCHIRURGICA (2022). 164:903¿911. DOI.ORG/10.1007/S00701-021-05039-Z.. EVENT SUMMARY: A RETROSPECTIVE SAFETY AND COMPLICATION-BASED ANALYSIS OF OCCIPITOCERVICAL FUSION VIA CONDYLAR SCREWS FIXATION WAS PERFORMED. THIS STUDY AIMS TO EVALUATE THE SAFETY PROFILE AND COMPLICATIONS OF CONDYLAR SCREW FIXATION FOR OCCIPITOCERVICAL FUSION. A TOTAL OF 250 PATIENTS UNDERWENT OCCIPITOCERVICAL FUSIONS USING 500 CONDYLAR SCREWS BETWEEN (B)(6) 2012 AND (B)(6) 2018. TWO HUNDRED SEVENTEEN PATIENTS WERE FEMALES. THE MEAN AGE WAS 36 ± 13.4 SD, RANGING FROM 6 TO 75. 23 PATIENTS WERE BELOW 18 YEARS OF AGE (RANGING 6 TO 17). FORTY-FOUR CASES WERE REVISION SURGERIES FROM A FORMER BARPLATE CONFIGURATION. INDICATIONS FOR REVISION OPERATIONS INCLUDED PAINFUL PROFILE, METAL FATIGUE, OR BAR-PLATE BREAKDOWN, ALONE OR IN COMBINATION. ONE HUNDRED EIGHTY PATIENTS (72%) HAD A FORMAL DIAGNOSIS OR CLINICAL EVIDENCE. OF A CONNEC
Patient problems: Nerve Damage
MAUDE report 16858483 ↗

Device details

UDI-DI	`00643169000896`
Brand	N/A
Model	X0411333
Company	Medtronic Sofamor Danek, Inc.
Product code	HTW · BIT, DRILL
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 29, 2018

Device type (GMDN): Drilling power tool attachment, basic

A device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a drilling function when an appropriate drill bit is inserted. It may include integral design features, e.g., have an angled head, be cannulated, have an attached Jacobs chuck, or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.

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All BIT, DRILL 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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