SureLOK Mini Posterior Cervical/Upper Thoracic System 04-9009-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840019920346), received between Jan 9, 2026 and Jan 9, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Fracture

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2025, UTILIZING THE SURELOK POSTERIOR CERVICAL SYSTEM. DURING THE FINAL TORQUE, THE SURGEON USED THE ANTI-TORQUE TOOL ON THE SCREW HEAD WHILE TIGHTENING IN THE OPPOSITE DIRECTION OF THE NUT. AT THAT MOMENT, THE T-15 HEXALOBE TORQUE DRIVER (04-9097) BROKE. THE BROKEN PIECE WAS REMOVED AND THE PROCEDURE CONTINUED. WHEN ATTEMPTING TO USE THE TAP TO CUT THE THREAD FOR THE SCREW WITH THE DESIRED SIZE, IT BROKE ONCE IT REACHED HALFWAY INTO THE SCREW'S DIAMETER, WHICH WAS 12 MM AND 3.5 MM IN DIAMETER. THE BROKEN PART OF THE TAP WAS EASILY REMOVED FROM THE PATIENT. THE SURGICAL TEAM PROCEEDED BY USING A DRILL TO COMPLETE THE TRAJECTORY, AND SINCE ONE OF THE FEATURES OF THE POSTERIOR CERVICAL SCREW IS THAT IT IS SELF-TAPPING, THE SCREW WAS ABLE TO ENGAGE AND ADVANCE PROPERLY ONCE THE INITIAL PATHWAY WAS PREPARED. THE PROCEDURE WAS COMPLETED WITH JUST A TWO MINUTE DELAY AND NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24028936 ↗