Anchor Bolt Kit, LSB Style LSBK1-AX-06Recalls & reported problems
Ad-Tech Medical Instrument Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841823104274), received between Apr 2, 2019 and May 17, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break2
- Material Separation2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 17, 2019Break; Material Separation; Break; Material Separation
ON (B)(6) 2019 AD-TECH RECEIVED AN EMAIL FROM A CUSTOMER IN REGARDS TO AN ISSUE THEY EXPERIENCED IN A CASE ON (B)(6) 2019 WITH AN AD-TECH ANCHOR BOLT. IT WAS REPORTED THAT PART OF THE SCREW REMAINED IN THE CRANIAL VAULT OF THE PATIENT. ACCORDING TO THE CUSTOMER, THE SCREW BROKE DURING ELECTRODE IMPLANTATION. THERE IS NO KNOWN IMPACT TO PATIENT SAFETY. REMOVAL OF THE BOLT WAS SCHEDULE TO OCCUR AFTER RECORDINGS HAD BEEN TAKEN (I.E., 5 TO 10 DAYS).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8619340 ↗MalfunctionApr 2, 2019Break; Material Separation; Break; Material Separation
ON MARCH 15, 2019, AD-TECH RECEIVED A COPY OF A MEDWATCH 3500A REPORT FROM THE FOOD AND DRUG ADMINISTRATION (FDA). THE REPORT WAS FROM A USER FACILITY (UF), DOCUMENTED UNDER UF REPORT # (B)(4). ACCORDING TO THE FORM, IT WAS STATED THAT, "... WHEN INSERTING THE ANCHOR BOLT, THE BOLT SNAPPED..." PART OF THE BOLT REMAINED IN THE SKULL AND A NEEDLE DRIVER WAS USED TO SECURE THE ANCHOR BOLT, THUS ENABLING THE BOLT TO BE UNSCREWED FOR REMOVAL. ACCORDING TO THE USER FACILITY, THEY WERE NOT AWARE OF ANY OTHER INFORMATION ABOUT THE PATIENT THAT MAY HAVE INFLUENCED THE OUTCOME OF THE EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8472930 ↗
Other Electrode, Depth devices
- Spencer Probe Depth Electrode SD04R-AP58X-000Ad-Tech Medical Instrument Corporation · ELECTRODE, DEPTH1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- Spencer Probe Depth Electrode SD06R-AP58X-000Ad-Tech Medical Instrument Corporation · ELECTRODE, DEPTH1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- 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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