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Drill Guide Depth Control 41839-50Recalls & reported problems

Brainlab SE · Class 2

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 04056481003418), received between Jun 7, 2021 and Jun 7, 2021 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Use of Device Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • InjuryJun 7, 2021Use of Device Problem; Use of Device Problem

    AN OPEN SURGERY ON THE LUMBAR SPINE FOR LATERAL FUSION AND POSTERIOR DECOMPRESSION AT VERTEBRAE L3/L4 AND FUSION EXTENSION L3 TO L5 OF AN EXISTING FUSION, WITH INTENDED PLACEMENT OF 2 PEDICLE SCREWS, WAS PERFORMED WITH THE AID OF THE BRAINLAB SPINE&TRAUMA NAVIGATION SYSTEM. DURING THE PROCEDURE THE SURGEON: WITH THE PATIENT IN PRONE POSITION, ATTACHED THE NAVIGATION REFERENCE ARRAY ON THE PATIENT'S SPINE. ACQUIRED AN INTRA-OPERATIVE CT SCAN WITH AUTOMATIC IMAGE REGISTRATION MATCHING THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY, VERIFIED AND ACCEPTED THE REGISTRATION IN THE NAVIGATION. PREPARED THE PEDICLE (PILOT HOLE) AT RIGHT L3 WITH THE NAVIGATED DRILL GUIDE 3.2MM, BY DRILLING THROUGH THE GUIDE WITH THE MECHANICAL DEPTH CONTROL ATTACHED SET TO 35MM DEPTH, PLACED A K-WIRE, AND THE FOLLOWING PEDICLE SCREW 6X45MM ACCURATELY AS INTENDED WITH A SCREWDRIVER CALIBRATED TO NAVIGATION. WHEN PREPARING THE LEFT L3 PEDICLE PILOT HOLE WITH THE SAME METHOD, AFTER DRILLING WHEN REMOVING THE POWER DRILL REALIZED THAT THE DEPTH CONTROL DID NOT STOP THE DRILL AT 35MM DEPTH AS INTENDED, BUT INSTEAD THE DRILL HAD ADVANCED 10MM DEEPER INTO THE PEDICLE TO A TOTAL OF 45MM. SINCE AS PER

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11945190 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.