Anchor Bolt Kit, LSB Style LSBK1-AX-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00841823104267), received between Feb 22, 2017 and Dec 3, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2024Fracture; Fracture

  ON 11/8/2024 , TWO DAYS POST IMPLANTATION IT WAS DISCOVERED THAT THE ANCHOR BOLTS AND ELECTRODES WERE DAMAGED DUE TO PATIENT SEIZURES AND COMBATIVE BEHAVIOR. ONE ANCHOR BOLT WAS BENT AND THE OTHER ONE BROKEN OFF INTO 2 PIECES. THIS CAUSED BOTH ELECTRODES TO BE DAMAGED. THE PATIENT REQUIRED ADDITIONAL SURGERY FOR THE REMOVAL OF THE BROKEN ANCHOR BOLT AND REPLACEMENT OF THE ELECTRODES.

  Patient problems: Foreign Body In Patient

  MAUDE report 20834260 ↗
• MalfunctionSep 24, 2021Material Integrity Problem; Material Integrity Problem

  ON (B)(6) 2021 AD-TECH'S (B)(6) DISTRIBUTOR SENT A REPORT FROM A CUSTOMER ABOUT AN ISSUE THAT OCCURRED ON (B)(6) 2017. IT WAS REPORTED THAT DURING PLACEMENT, AN ANCHOR BOLT BROKE AND A PIECE REMAINED IN THE PATIENT'S SKULL. THE REMAINING PIECE WAS REMOVED DURING AN ADDITIONAL PROCEDURE AND THERE WAS NO HARMFUL IMPACT TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12526153 ↗
• MalfunctionSep 13, 2018Break; Material Separation; Break; Material Separation

  ON AUGUST 14, 2018 AD-TECH'S CLINICAL SPECIALIST RECEIVED A PHONE CALL FROM A CUSTOMER STATING THAT 2 ANCHOR BOLTS HAD SHEARED OFF AT THE THREADS. ONE BOLT HAD SHEARED OFF WHILE BEING SCREWED INTO THE SKULL DURING IMPLANTATION AND THE NEUROSURGEON DRILLED OUT THE THREADED PORTION. THE SECOND SHEARED BOLT WAS FOUND 6 DAYS POST-OP. THE THREADS STILL REMAIN IN THE SKULL AND WILL BE DRILLED OUT DURING EX-PLANTATION. TO DATE, IT IS UNKNOWN WHAT THE CURRENT STATUS IS OF THE PATIENT. IT WAS STATED THAT SPECIFIC TO THE SHEARED BOLT SEEN DURING IMPLANTATION, THE TRAJECTORY WAS SCRAPPED AND RE-PLANNED.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7873064 ↗
• MalfunctionApr 27, 2018Break; Material Separation; Break; Material Separation

  ON 3/29/2018, THE AD-TECH CLINICAL SPECIALIST RECEIVED AN EMAIL FROM A DISTRIBUTOR STATING THAT THEY WERE INFORMED BY ONE OF THEIR CUSTOMERS THAT DURING A CASE, TWO AD-TECH ANCHOR BOLTS "FELL OFF" A FEW DAYS AFTER IMPLANTATION. A CT SCAN WAS PERFORMED AND THE "DISTAL SCREW PART" OF THE ANCHOR BOLTS REMAINED IN THE PATIENT, WHICH SHOWED THAT THE ANCHOR BOLTS WERE SNAPPED AFTER IMPLANTATION. A SECOND SURGERY WAS SCHEDULED TO REMOVE ALL THE ELECTRODES WITH ANCHOR BOLTS ON (B)(6) 2018. THE DISTRIBUTOR STATED THAT THE PATIENT WAS EXPERIENCING A FEVER AND THE HOSPITAL DID NOT KNOW IF THIS WAS DUE TO THE OPEN WOUND FROM THE BROKEN ANCHOR BOLTS OR OTHER CLINICAL REASONS. AD-TECH RESPONDED BACK TO THE CUSTOMER THE DAY THEY WERE NOTIFIED TO OBTAIN ADDITIONAL INFORMATION TO HELP AID WITH THE COMPLAINT INVESTIGATION. TO DATE, THE CUSTOMER HAS NOT RESPONDED BACK. IT IS UNKNOWN WHAT THE OUTCOME OR CURRENT STATUS IS OF THE PATIENT. A SUPPLEMENT REPORT WILL BE INITIATED SHOULD AD-TECH RECEIVE ADDITIONAL INFORMATION RELEVANT TO THIS MEDWATCH REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7469504 ↗
• MalfunctionApr 18, 2018Break; Material Separation; Break; Material Separation

  ON 3/19/2018, THE AD-TECH CLINICAL SPECIALIST RECEIVED AN EMAIL FROM A DISTRIBUTOR STATING THAT THEY WERE INFORMED BY ONE OF THEIR CUSTOMERS THAT AN AD-TECH ANCHOR BOLT BROKE AFTER IMPLANTATION. AD-TECH RESPONDED BACK TO THE CUSTOMER THAT DAY TO OBTAIN ADDITIONAL INFORMATION TO HELP AID WITH THE COMPLAINT INVESTIGATION. TO DATE, THE CUSTOMER HAS NOT RESPONDED BACK. IT IS UNKNOWN WHAT THE OUTCOME OR CURRENT STATUS IS OF THE PATIENT. A SUPPLEMENT REPORT WILL BE INITIATED SHOULD AD-TECH RECEIVE ADDITIONAL INFORMATION RELEVANT TO THIS MEDWATCH REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7441803 ↗
• MalfunctionSep 14, 2017Break; Material Separation; Break; Material Separation

  AD-TECH WAS MADE AWARE OF AN ISSUE ON (B)(6) 2017. DURING AN SEEG/ROSA DEPTH CASE, WHILE ATTEMPTING TO PLACE AN ANCHOR BOLT FOR ONE OF THE TRAJECTORIES THE BOLT BROKE. THE DOCTOR STATED THAT THE BONE WAS THICK AND WHEN ATTEMPTING TO SCREW THE BOLT INTO THE BONE, SOME RESISTANCE WAS FELT AND THE WRENCH STARTED TO TURN VERY EASILY. AT THIS POINT IT WAS IDENTIFIED THAT THE BASE OF THE ANCHOR BOLT BROKE OFF AT THE TOP OF THE THREADS. AN INCISION AND A SLIGHT CRANIECTOMY HAD TO BE MADE TO RETRIEVE THE BROKEN BOLT AND SOME OF THE BOLT WAS LEFT BEHIND. ACCORDING TO THE DOCTOR, THERE WAS NO SERIOUS INJURY TO THE PATIENT AS A RESULT OF THIS ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6867065 ↗
• MalfunctionFeb 22, 2017Break; Material Separation; Break; Material Separation

  AD-TECH WAS MADE AWARE OF AN ISSUE ON 2/10/2017. IT WAS FOUND THAT THE PATIENT HAD 12 CRANIAL ANCHOR BOLTS IMPLANTED ON (B)(6) 2016 AND EXPLANTED ON (B)(6) 2016. THE PATIENT HAD UNREMARKABLE SEIZURES WHILE LYING IN BED, NO FALLS OR HITTING OF THEIR HEAD. UPON EXAMINATION, IT WAS FOUND THAT THE PATIENT HAD 2 BROKEN BOLTS. THE PATIENT REQUIRED MORE EXTENSIVE REMOVAL OF THE BROKEN BOLTS AS THE BOLTS WERE BROKEN IN THE HEAD BELOW THE SKIN. TO DATE, THERE HAVE BEEN NO REPORTS IN REGARDS TO NEGATIVE IMPACT TO PATIENT SAFETY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6349390 ↗