Anchor Bolt Kit, LSB Style LSBK2-BX-04Recalls & 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 00841823104342), received between Feb 20, 2020 and Feb 20, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Flaked” (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
- Flaked2
- Device Difficult to Setup or Prepare1
Patient problems
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
ON (B)(6) 2018 AD-TECH RECEIVED AN EMAIL FROM A DISTRIBUTOR ABOUT AN ISSUE THEIR CUSTOMER EXPERIENCED IN A CASE USING AD-TECH ANCHOR BOLTS. SPECIFICALLY, "WE HAD SEEG CASE ON LAST SATURDAY, SURGEON JUST NOTICED THAT CFS LEAKED FROM ANCHOR BOLT AS ATTACHMENT." FURTHER CORRESPONDENCE INDICATED THAT THE SURGEON NOTICED THE CSF (CEREBRAL SPINAL FLUID) LEAKAGE AFTER HE PLACED THE SILICONE CAP ON THE ANCHOR BOLT. THE LEAKAGE WAS COMING FROM THE GAP BETWEEN THE ELECTRODE AND THE TOP OF THE CAP, AFTER THE SILICONE CAP WAS SECURED ON ANCHOR BOLT CAP. IT WAS THEN STATED THAT AFTER THE PATIENT WAS TRANSFERRED TO THE WARD, IT SEEMED THAT THE CSF STOPPED LEAKING AND EVERYTHING SEEMED TO BE OK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9734954 ↗MalfunctionFeb 20, 2020Flaked; Flaked
ON (B)(6) 2018, AD-TECH RECEIVED A COMPLAINT FROM AN INDEPENDENT REPRESENTATIVE STATING THAT "GOLD DUST" WAS IDENTIFIED IN AN AD-TECH ANCHOR BOLT PRIOR TO USE AT THE CUSTOMER SITE. NO KNOWN IMPACT TO PATIENT SAFETY AS THE ISSUE WAS IDENTIFIED PRIOR TO USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9732983 ↗MalfunctionFeb 20, 2020Flaked; Flaked
ON 5/18/2018, AN AD-TECH REPRESENTATIVE INFORMED THE AD-TECH CHIEF OPERATING OFFICER OF A SITUATION IN WHICH BURRS WERE IDENTIFIED ON AD-TECH ANCHOR BOLT. THERE WAS NO KNOWN IMPACT TO PATIENT SAFETY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9732913 ↗
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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