SureLOK MIS 3L 63-9012Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840019919920), received between Dec 1, 2023 and Dec 1, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• InjuryDec 1, 2023Break; Break

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED BY ON (B)(6) 2023, IN SAUDI ARABIA, UTILIZING THE SURLOK MIS 3L PEDICLE SCREW SYSTEM. AFTER INSERTING THE SCREW, WHILE PULLING THE PERC SCREWDRIVER, SHORT (63-9012) OUT, IT GOT BROKEN AND SMALL PIECES STAYED IN THE PATIENT. THE SURGEON HAD TO MAKE AN INCISION TO TAKE IT OUT PRIOR TO CLOSURE AND AS A RESULT THERE WAS A FORTY (40) MINUTE DELAY TO THE PROCEDURE. THIS OCCURRED ON THE FINAL SCREW SO NO ADDITIONAL INSTRUMENTATION WAS REQUIRED FOLLOWING THE MALFUNCTION OF THE DRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18251243 ↗