Anchor Bolt Kit, LSB Style LSBK1-BX-05Recalls & reported problems
Ad-Tech Medical Instrument Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841823104281), received between Nov 9, 2023 and Feb 7, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (2 reports).
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
Most reported problems
Device problems
- Material Integrity Problem2
- Fracture1
Patient problems
- Foreign Body In Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 7, 2024Fracture; Fracture
ON (B)(6) 2024 TWO ANCHOR BOLTS BROKE OFF DURING A SEEG SURGICAL PROCEDURE. THE SURGEON WAS REQUIRED TO DRILL AROUND THE SITE (LOCATION OF THE ANCHOR BOLT) TO INCREASE THE SIZE OF THE HOLE TO REMOVE THE BOLT AND ITS SMALLER PIECES. THERE WAS NO PATIENT HARM OR INJURY REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 18660337 ↗MalfunctionDec 14, 2023Material Integrity Problem; Material Integrity Problem
PATIENT WAS UNDERGOING REMOVAL OF ELECTRODE BOLTS WHEN TWO OF THESE FRACTURED DURING REMOVAL, REQUIRING ADDITONAL OPERATIVE MANEUVERS (INCISION, PARTIAL SKULL THICKNESS BONE REMOVAL) TO ACHIEVE COMPLETE DEVICE EXTRACTION UNDER THE SAME ANESTHETIC.
Patient problems: Foreign Body In Patient
MAUDE report 18326947 ↗MalfunctionNov 9, 2023Material Integrity Problem; Material Integrity Problem
UPON THE REMOVAL OF THE HEAD WRAP THE SURGEON NOTED THAT AN ANCHOR BOLT WAS BROKEN. ADDITIONAL MEDICAL INTERVENTION WAS NEEDED TO REMOVE THE BOLT; HOWEVER THERE WAS NO HARM OR INJURY TO THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 18102264 ↗
Other Electrode, Depth devices
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- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
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- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
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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